RELAX-AHF-2: Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01870778

Collaborator

(none)

6,600

Enrollment

542

Locations

Arms

Actual Duration (Months)

12.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure	Drug: RLX030 Drug: Placebo	Phase 3

Detailed Description

This Phase IIIb outcome study in AHF patients was designed as a multicenter, randomized, double-blind, placebo-controlled, event-driven study in order to assess the efficacy, safety and tolerability of intravenous infusion of serelaxin or placebo. The AHF patients randomized to either serelaxin or placebo in the study were followed for a period of 180 days, and were required to receive standard-of-care background HF management during both the index hospitalization and post discharge according to regional or local guidelines/institutional standards.

Study Design

Study Type:

Interventional

Actual Enrollment :

6600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

Actual Study Start Date :

Oct 2, 2013

Actual Primary Completion Date :

Jan 23, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Serelaxin (RLX030) Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Drug: RLX030 1 mg/mL solution in 6 mL vials
Placebo Comparator: Placebo Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.	Drug: Placebo Matching placebo solution to serelaxin

Arm

Intervention/Treatment

Experimental: Serelaxin (RLX030)

Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.

Drug: RLX030

1 mg/mL solution in 6 mL vials

Placebo Comparator: Placebo

Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.

Drug: Placebo

Matching placebo solution to serelaxin

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180 [180 days]
The percentage of participants with an adjudicated CV death through day 180 was assessed.
Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5 [Day 5]
The percentage of participants with WHF through day 5 was assessed.

Secondary Outcome Measures

Percentage of Participants With All-cause Death Through Day 180 [180 days]
The percentage of participants with all-cause death through day 180 was assessed.
Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization [180 days (Participants still in the hospital at Day 60 were censored at Day 60)]
Length of stay was defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day.
Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization [180 days]
The percentage of participants with adjudicated CV death or adjudicated re-hospitalization through day 180 was assessed.
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization [180 days (Patients still in the hospital at Day 60 were censored at Day 60)]
Length of stay was defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day.
Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure [From baseline to Day 5]
The percentage of participants with first improvement since baseline in congestive signs and symptoms was assessed. The signs and symptoms included exertional dyspnea, orthopnea, rales, jugular venous pressure and peripheral edema/pre-sacral edema.
Change From Baseline in hsTroponin T Biomarker [Baseline, Day 2, Day 5 and Day 14]
Blood samples were collected to assess the change from baseline in hsTroponin T. The geometric least square mean (LSM) of the ratio of the post-baseline value to the baseline value is presented.
Change From Baseline in NT-proBNP Biomarker [Baseline, Day 2, Day 5 and Day 14]
Blood samples were collected to assess the change from baseline in NT-proBNP. The ratio of the post-baseline value to the baseline value is presented.
Change From Baseline in Cystatin C Biomarker [Baseline, Day 2, Day 5 and Day 14]
Blood samples were collected to assess the change from baseline in Cystatin C. The ratio of the post-baseline value to the baseline value is presented.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Male or female 18 years of age, with body weight ≤160 kg
Hospitalized for AHF with anticipated requirement of IV therapy for at least 48 hours; AHF is defined as including all of the following measured at any time between presentation (including the emergency department) and the end of screening:
Persistent dyspnea at rest or with minimal exertion
Pulmonary congestion on chest radiograph
B-type natriuretic peptide (BNP) ≥500 pg/mL or N-terminal (NT)-proBNP ≥2000 pg/mL; for patients ≥ 75 years of age or with current atrial fibrillation (at the time of randomization), BNP ≥ 750 pg/mL or NT-proBNP ≥ 3,000 pg/mL
Systolic BP ≥125 mmHg at the start and at the end of screening
Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode.

Key Exclusion Criteria:

Dyspnea primarily due to non-cardiac causes
Known history of respiratory disorders requiring the daily use of IV or oral steroids (does not include inhaled steroids); need for intubation or the current use of IV or oral steroids for chronic obstructive pulmonary disease (COPD)
Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
Patients with severe renal impairment defined as pre-randomization estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73m2 calculated using the Simplified Modification of Diet in Renal Disease (sMDRD) equation, and/or those receiving current or planned dialysis or ultrafiltration
Patients with hematocrit <25%, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding.
Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased ammonia levels, if performed) or history of cirrhosis with evidence of portal hypertension such as varices.
Significant, uncorrected, left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >40 mmHg on prior or current echocardiogram), and severe mitral stenosis
Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated.
Documented, prior to or at the time of randomization, restrictive amyloid myocardiopathy, OR acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does NOT include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Huntsville	Alabama	United States	35801
2	Novartis Investigative Site	Montgomery	Alabama	United States	36106
3	Novartis Investigative Site	Tucson	Arizona	United States	85723-0001
4	Novartis Investigative Site	Anaheim	California	United States	92801
5	Novartis Investigative Site	Fresno	California	United States	93720
6	Novartis Investigative Site	Loma Linda	California	United States	92354
7	Novartis Investigative Site	Los Angeles	California	United States	90033
8	Novartis Investigative Site	Los Angeles	California	United States	90073
9	Novartis Investigative Site	Los Angeles	California	United States	90095
10	Novartis Investigative Site	Northridge	California	United States	91325
11	Novartis Investigative Site	Palo Alto	California	United States	94304-1207
12	Novartis Investigative Site	Sacramento	California	United States	95817-1460
13	Novartis Investigative Site	San Diego	California	United States	92103
14	Novartis Investigative Site	San Diego	California	United States	92123
15	Novartis Investigative Site	San Diego	California	United States	92161
16	Novartis Investigative Site	Sylmar	California	United States	91342
17	Novartis Investigative Site	Walnut Creek	California	United States	94598
18	Novartis Investigative Site	Colorado Springs	Colorado	United States	80909
19	Novartis Investigative Site	Denver	Colorado	United States	80204-4507
20	Novartis Investigative Site	Hartford	Connecticut	United States	06102
21	Novartis Investigative Site	Hartford	Connecticut	United States	06105
22	Novartis Investigative Site	Atlantis	Florida	United States	33462
23	Novartis Investigative Site	Jacksonville	Florida	United States	32207
24	Novartis Investigative Site	Jacksonville	Florida	United States	32209
25	Novartis Investigative Site	Jacksonville	Florida	United States	32216
26	Novartis Investigative Site	Sanford	Florida	United States	32771
27	Novartis Investigative Site	Sarasota	Florida	United States	34239
28	Novartis Investigative Site	Tampa	Florida	United States	33606
29	Novartis Investigative Site	Tampa	Florida	United States	33612
30	Novartis Investigative Site	Winter Haven	Florida	United States	33881
31	Novartis Investigative Site	Atlanta	Georgia	United States	30310
32	Novartis Investigative Site	Atlanta	Georgia	United States	30342
33	Novartis Investigative Site	Marietta	Georgia	United States	30060
34	Novartis Investigative Site	Chicago	Illinois	United States	60637
35	Novartis Investigative Site	Elk Grove Village	Illinois	United States	60007
36	Novartis Investigative Site	Oakbrook Terrace	Illinois	United States	60181
37	Novartis Investigative Site	Peoria	Illinois	United States	61602
38	Novartis Investigative Site	Indianapolis	Indiana	United States	46202-5111
39	Novartis Investigative Site	Indianapolis	Indiana	United States	46237
40	Novartis Investigative Site	Muncie	Indiana	United States	47303-3400
41	Novartis Investigative Site	Kansas City	Kansas	United States	66160
42	Novartis Investigative Site	Alexandria	Louisiana	United States	71301
43	Novartis Investigative Site	Baton Rouge	Louisiana	United States	70808
44	Novartis Investigative Site	Covington	Louisiana	United States	70433
45	Novartis Investigative Site	New Orleans	Louisiana	United States	70112
46	Novartis Investigative Site	Annapolis	Maryland	United States	21401
47	Novartis Investigative Site	Baltimore	Maryland	United States	21201
48	Novartis Investigative Site	Baltimore	Maryland	United States	21287
49	Novartis Investigative Site	Boston	Massachusetts	United States	02114
50	Novartis Investigative Site	Boston	Massachusetts	United States	02115
51	Novartis Investigative Site	Boston	Massachusetts	United States
52	Novartis Investigative Site	Worcester	Massachusetts	United States	01655
53	Novartis Investigative Site	Detroit	Michigan	United States	48201
54	Novartis Investigative Site	Detroit	Michigan	United States	48202
55	Novartis Investigative Site	Detroit	Michigan	United States	48235
56	Novartis Investigative Site	Minneapolis	Minnesota	United States	55417
57	Novartis Investigative Site	Jackson	Mississippi	United States	39216
58	Novartis Investigative Site	Picayune	Mississippi	United States	39466
59	Novartis Investigative Site	Kansas City	Missouri	United States	64108
60	Novartis Investigative Site	Saint Louis	Missouri	United States	63110
61	Novartis Investigative Site	Saint Louis	Missouri	United States	63128
62	Novartis Investigative Site	Saint Louis	Missouri	United States	63136
63	Novartis Investigative Site	Omaha	Nebraska	United States	68198
64	Novartis Investigative Site	Bronx	New York	United States	10461
65	Novartis Investigative Site	Bronx	New York	United States	10467-2490
66	Novartis Investigative Site	Brooklyn	New York	United States	11203
67	Novartis Investigative Site	Brooklyn	New York	United States	11215
68	Novartis Investigative Site	Kingston	New York	United States	12401
69	Novartis Investigative Site	New Hyde Park	New York	United States	11040
70	Novartis Investigative Site	Rochester	New York	United States	14642
71	Novartis Investigative Site	Stony Brook	New York	United States	11794
72	Novartis Investigative Site	Chapel Hill	North Carolina	United States	27599-7075
73	Novartis Investigative Site	Durham	North Carolina	United States	27710
74	Novartis Investigative Site	Raleigh	North Carolina	United States	27610
75	Novartis Investigative Site	Canton	Ohio	United States	44710
76	Novartis Investigative Site	Cincinnati	Ohio	United States	45220
77	Novartis Investigative Site	Cincinnati	Ohio	United States	45267-0585
78	Novartis Investigative Site	Cleveland	Ohio	United States	44195
79	Novartis Investigative Site	Columbus	Ohio	United States	43210
80	Novartis Investigative Site	Toledo	Ohio	United States	43614
81	Novartis Investigative Site	Portland	Oregon	United States	97219
82	Novartis Investigative Site	Abington	Pennsylvania	United States	19001
83	Novartis Investigative Site	Natrona Heights	Pennsylvania	United States	15065
84	Novartis Investigative Site	Philadelphia	Pennsylvania	United States	19102 2293
85	Novartis Investigative Site	Philadelphia	Pennsylvania	United States	19107
86	Novartis Investigative Site	Wynnewood	Pennsylvania	United States	19096
87	Novartis Investigative Site	Providence	Rhode Island	United States	02903
88	Novartis Investigative Site	Warwick	Rhode Island	United States	02886
89	Novartis Investigative Site	Greenville	South Carolina	United States	29607
90	Novartis Investigative Site	Greenville	South Carolina	United States	29615
91	Novartis Investigative Site	Nashville	Tennessee	United States	37203
92	Novartis Investigative Site	Nashville	Tennessee	United States	37212
93	Novartis Investigative Site	Dallas	Texas	United States	75216
94	Novartis Investigative Site	Dallas	Texas	United States	75226
95	Novartis Investigative Site	Galveston	Texas	United States	77555
96	Novartis Investigative Site	Houston	Texas	United States	77030
97	Novartis Investigative Site	San Antonio	Texas	United States	78229
98	Novartis Investigative Site	San Antonio	Texas	United States	78234
99	Novartis Investigative Site	Charlottesville	Virginia	United States	22908
100	Novartis Investigative Site	Falls Church	Virginia	United States	22042
101	Novartis Investigative Site	Lynchburg	Virginia	United States	24501
102	Novartis Investigative Site	Roanoke	Virginia	United States	24014
103	Novartis Investigative Site	Seattle	Washington	United States	98101
104	Novartis Investigative Site	Seattle	Washington	United States	98122
105	Novartis Investigative Site	Morgantown	West Virginia	United States	26506
106	Novartis Investigative Site	Caba	Buenos Aires	Argentina	C1180AAX
107	Novartis Investigative Site	Caba	Buenos Aires	Argentina	C1280AEB
108	Novartis Investigative Site	Carapachay	Buenos Aires	Argentina	B1605
109	Novartis Investigative Site	Coronel Suarez	Buenos Aires	Argentina	B7540GHD
110	Novartis Investigative Site	La Plata	Buenos Aires	Argentina	B1900AWT
111	Novartis Investigative Site	San Martin	Buenos Aires	Argentina	B1650CSQ
112	Novartis Investigative Site	San Salvador de Jujuy	Jujuy	Argentina	Y4600ABF
113	Novartis Investigative Site	Rosario	Santa Fe	Argentina	C2000DSR
114	Novartis Investigative Site	Rosario	Santa Fe	Argentina	S2000DSV
115	Novartis Investigative Site	Rosario	Santa Fe	Argentina	S2001ODA
116	Novartis Investigative Site	Rosario	Santa Fe	Argentina	S2001SBL
117	Novartis Investigative Site	San Miguel de Tucuman	Tucuman	Argentina	T4000JCU
118	Novartis Investigative Site	Buenos Aires		Argentina	B1602ABQ
119	Novartis Investigative Site	Buenos Aires		Argentina	B1846BMF
120	Novartis Investigative Site	Buenos Aires		Argentina	C1039AAP
121	Novartis Investigative Site	Buenos Aires		Argentina	C1120AAF
122	Novartis Investigative Site	Buenos Aires		Argentina	C1405CNF
123	Novartis Investigative Site	Buenos Aires		Argentina	C1425AGP
124	Novartis Investigative Site	Buenos Aires		Argentina	C1428DCO
125	Novartis Investigative Site	Buenos Aires		Argentina	W3400ABH
126	Novartis Investigative Site	Cordoba		Argentina	X5000AAX
127	Novartis Investigative Site	Cordoba		Argentina	X5000EPU
128	Novartis Investigative Site	Cordoba		Argentina	X5004BAL
129	Novartis Investigative Site	Cordoba		Argentina	X5004CDT
130	Novartis Investigative Site	Cordoba		Argentina	X5006IKK
131	Novartis Investigative Site	Cordoba		Argentina	X5009BSN
132	Novartis Investigative Site	Cordoba		Argentina	X5016KET
133	Novartis Investigative Site	Corrientes		Argentina	W3400CBI
134	Novartis Investigative Site	Corrientes		Argentina	W3400
135	Novartis Investigative Site	Formosa		Argentina	P3600
136	Novartis Investigative Site	Salta		Argentina	A4400
137	Novartis Investigative Site	Santa Fe		Argentina	S3000EOZ
138	Novartis Investigative Site	Santa Fe		Argentina	S3000FUJ
139	Novartis Investigative Site	Tucuman		Argentina	T4000NIJ
140	Novartis Investigative Site	Camperdown	New South Wales	Australia	2050
141	Novartis Investigative Site	Concord	New South Wales	Australia	2139
142	Novartis Investigative Site	Randwick	New South Wales	Australia	2031
143	Novartis Investigative Site	St Leonards	New South Wales	Australia	2065
144	Novartis Investigative Site	Herston	Queensland	Australia	4029
145	Novartis Investigative Site	Bedford Park	South Australia	Australia	5041
146	Novartis Investigative Site	Geelong	Victoria	Australia	3220
147	Novartis Investigative Site	Melbourne	Victoria	Australia	3004
148	Novartis Investigative Site	Murdoch	Western Australia	Australia	6150
149	Novartis Investigative Site	Perth	Western Australia	Australia	6000
150	Novartis Investigative Site	Innsbruck	Tyrol	Austria	6020
151	Novartis Investigative Site	Braunau		Austria	A5280
152	Novartis Investigative Site	Graz		Austria	A-8036
153	Novartis Investigative Site	Linz		Austria	4010
154	Novartis Investigative Site	Linz		Austria	A-4010
155	Novartis Investigative Site	Salzburg		Austria
156	Novartis Investigative Site	Villach		Austria	9500
157	Novartis Investigative Site	Wels		Austria	4600
158	Novartis Investigative Site	Wien		Austria	A-1090
159	Novartis Investigative Site	Aalst		Belgium	9300
160	Novartis Investigative Site	Brussels		Belgium	B-1070
161	Novartis Investigative Site	Bruxelles		Belgium	1200
162	Novartis Investigative Site	Genk		Belgium	3600
163	Novartis Investigative Site	Gent		Belgium	9000
164	Novartis Investigative Site	Kortrijk		Belgium	8500
165	Novartis Investigative Site	Leuven		Belgium	3000
166	Novartis Investigative Site	Mons		Belgium	7000
167	Novartis Investigative Site	Goiania	GO	Brazil	74605-020
168	Novartis Investigative Site	Curitiba	Parana	Brazil	80730 150
169	Novartis Investigative Site	Rio de Janeiro	RJ	Brazil	20551-030
170	Novartis Investigative Site	Porto Alegre	RS	Brazil	90035-003
171	Novartis Investigative Site	Porto Alegre	RS	Brazil	90880-480
172	Novartis Investigative Site	Ribeirao Preto	SP	Brazil	14048-900
173	Novartis Investigative Site	Sao Jose do Rio Preto	SP	Brazil	15090-000
174	Novartis Investigative Site	Sao Paulo	SP	Brazil	04012 909
175	Novartis Investigative Site	Sao Paulo	SP	Brazil	05303-000
176	Novartis Investigative Site	Pazardzhik		Bulgaria	4400
177	Novartis Investigative Site	Pleven		Bulgaria	5800
178	Novartis Investigative Site	Plovdiv		Bulgaria	4002
179	Novartis Investigative Site	Smolian		Bulgaria	4700
180	Novartis Investigative Site	Sofia		Bulgaria	1202
181	Novartis Investigative Site	Sofia		Bulgaria	1407
182	Novartis Investigative Site	Sofia		Bulgaria	1527
183	Novartis Investigative Site	Sofia		Bulgaria	1606
184	Novartis Investigative Site	Sofia		Bulgaria	1709
185	Novartis Investigative Site	Varna		Bulgaria	9010
186	Novartis Investigative Site	Calgary	Alberta	Canada	T2N 4Z6
187	Novartis Investigative Site	Toronto	Ontario	Canada	M5B 1N9
188	Novartis Investigative Site	Montreal	Quebec	Canada	H1T 1C8
189	Novartis Investigative Site	Sainte-Foy	Quebec	Canada	G1V 4G5
190	Novartis Investigative Site	Thetford Mines	Quebec	Canada	G6G 2V4
191	Novartis Investigative Site	Las Condes	Santiago	Chile	7560171
192	Novartis Investigative Site	Santiago		Chile
193	Novartis Investigative Site	Medellin	Antioquia	Colombia	050036
194	Novartis Investigative Site	Barranquilla		Colombia
195	Novartis Investigative Site	Florida Blanca		Colombia
196	Novartis Investigative Site	Brno - Bohunice	Czech Republic	Czechia	625 00
197	Novartis Investigative Site	Frydek Mistek	Czech Republic	Czechia	73801
198	Novartis Investigative Site	Kladno	Czech Republic	Czechia	272 00
199	Novartis Investigative Site	Liberec	Czech Republic	Czechia	46063
200	Novartis Investigative Site	Pardubice	Czech Republic	Czechia	532 03
201	Novartis Investigative Site	Praha 6	Czech Republic	Czechia	169 02
202	Novartis Investigative Site	Slany	Czech Republic	Czechia	27401
203	Novartis Investigative Site	Usti nad Labem	Czech Republic	Czechia	400 11
204	Novartis Investigative Site	Usti nad Orlici	Czech Republic	Czechia	562 18
205	Novartis Investigative Site	Zlin	Czech Republic	Czechia	76275
206	Novartis Investigative Site	Hradec Kralove	CZE	Czechia	500 05
207	Novartis Investigative Site	Benesov		Czechia	25601
208	Novartis Investigative Site	Brno		Czechia	636 00
209	Novartis Investigative Site	JIhlava		Czechia	586 01
210	Novartis Investigative Site	Kolin		Czechia	280 20
211	Novartis Investigative Site	Plzen		Czechia	301 00
212	Novartis Investigative Site	Praha 10		Czechia	100 34
213	Novartis Investigative Site	Praha		Czechia	12808
214	Novartis Investigative Site	Copenhagen NV		Denmark	DK-2400
215	Novartis Investigative Site	Glostrup		Denmark	2600
216	Novartis Investigative Site	Glostrup		Denmark	DK-2600
217	Novartis Investigative Site	Randers		Denmark	8930
218	Novartis Investigative Site	Amiens		France	80054
219	Novartis Investigative Site	Besancon cedex		France	25030
220	Novartis Investigative Site	Beziers Cedex		France	34525
221	Novartis Investigative Site	Bobigny		France	93009
222	Novartis Investigative Site	Caen		France	14000
223	Novartis Investigative Site	Chambray-lès-Tours		France	37170
224	Novartis Investigative Site	La Tronche		France	38700
225	Novartis Investigative Site	Le Chesnay		France	78157
226	Novartis Investigative Site	Le Chesnay		France
227	Novartis Investigative Site	Lille		France	59037
228	Novartis Investigative Site	Lille		France	59042
229	Novartis Investigative Site	Nancy		France	54035
230	Novartis Investigative Site	Paris cedex 10		France	75010
231	Novartis Investigative Site	Paris cedex 18		France	75877
232	Novartis Investigative Site	Paris		France	75015
233	Novartis Investigative Site	Pessac cedex		France	33604
234	Novartis Investigative Site	Pontoise		France	F-95300
235	Novartis Investigative Site	Rouen		France	76000
236	Novartis Investigative Site	Saint Herblain - Nantes		France	44093
237	Novartis Investigative Site	Toulouse		France	31054
238	Novartis Investigative Site	Tourcoing		France	59208
239	Novartis Investigative Site	Koeln	Nordrhein-Westfalen	Germany	50937
240	Novartis Investigative Site	Bad Krozingen		Germany	79189
241	Novartis Investigative Site	Berlin		Germany	10117
242	Novartis Investigative Site	Berlin		Germany	12203
243	Novartis Investigative Site	Berlin		Germany	12621
244	Novartis Investigative Site	Berlin		Germany	13347
245	Novartis Investigative Site	Berlin		Germany	13353
246	Novartis Investigative Site	Berlin		Germany	13509
247	Novartis Investigative Site	Berlin		Germany	13578
248	Novartis Investigative Site	Bitburg		Germany	54634
249	Novartis Investigative Site	Bochum		Germany	44791
250	Novartis Investigative Site	Bonn		Germany	53105
251	Novartis Investigative Site	Bonn		Germany	53115
252	Novartis Investigative Site	Brandenburg		Germany	16321
253	Novartis Investigative Site	Bremen		Germany	28277
254	Novartis Investigative Site	Coburg		Germany	96450
255	Novartis Investigative Site	Detmold		Germany	32756
256	Novartis Investigative Site	Dortmund		Germany	44137
257	Novartis Investigative Site	Dortmund		Germany	44379
258	Novartis Investigative Site	Dresden		Germany	01067
259	Novartis Investigative Site	Erfurt		Germany	99084
260	Novartis Investigative Site	Erfurt		Germany	99089
261	Novartis Investigative Site	Essen		Germany	45122
262	Novartis Investigative Site	Essen		Germany	45356
263	Novartis Investigative Site	Frankfurt		Germany	60488
264	Novartis Investigative Site	Frankfurt		Germany	60590
265	Novartis Investigative Site	Frankfurt		Germany	65929
266	Novartis Investigative Site	Freiburg		Germany	79106
267	Novartis Investigative Site	Friedberg		Germany	86316
268	Novartis Investigative Site	Füssen		Germany	87629
269	Novartis Investigative Site	Goettingen		Germany	37075
270	Novartis Investigative Site	Greifswald		Germany	17475
271	Novartis Investigative Site	Göttingen		Germany	37073
272	Novartis Investigative Site	Halle Saale		Germany	06120
273	Novartis Investigative Site	Hamburg		Germany	20246
274	Novartis Investigative Site	Hamburg		Germany	22291
275	Novartis Investigative Site	Heilbronn		Germany	74078
276	Novartis Investigative Site	Jena		Germany	07740
277	Novartis Investigative Site	Kiel		Germany	24105
278	Novartis Investigative Site	Kleve		Germany	47533
279	Novartis Investigative Site	Koeln-Nippes		Germany	50733
280	Novartis Investigative Site	Langen		Germany	63225
281	Novartis Investigative Site	Leipzig		Germany	04103
282	Novartis Investigative Site	Leverkusen		Germany	51375
283	Novartis Investigative Site	Limburg		Germany	65549
284	Novartis Investigative Site	Ludwigshafen		Germany	67063
285	Novartis Investigative Site	Lübeck		Germany	23569
286	Novartis Investigative Site	Magdeburg		Germany	39104
287	Novartis Investigative Site	Magdeburg		Germany	39120
288	Novartis Investigative Site	Mainz		Germany	55131
289	Novartis Investigative Site	Merseburg		Germany	06217
290	Novartis Investigative Site	Muenchen		Germany	80636
291	Novartis Investigative Site	Mönchengladbach		Germany	41063
292	Novartis Investigative Site	Neuwied		Germany	56564
293	Novartis Investigative Site	Oldenburg		Germany	26133
294	Novartis Investigative Site	Regensburg		Germany	93053
295	Novartis Investigative Site	Ruesselsheim		Germany	65428
296	Novartis Investigative Site	Tuebingen		Germany	72076
297	Novartis Investigative Site	Ulm		Germany	89081
298	Novartis Investigative Site	Villingen-Schwenningen		Germany	78052
299	Novartis Investigative Site	Weiden		Germany	92637
300	Novartis Investigative Site	Witten		Germany	58455
301	Novartis Investigative Site	Wuerzburg		Germany	97078
302	Novartis Investigative Site	Wuppertal		Germany	42117
303	Novartis Investigative Site	Zwickau		Germany	08060
304	Novartis Investigative Site	Athens	GR	Greece	14233
305	Novartis Investigative Site	Larissa	GR	Greece	411 10
306	Novartis Investigative Site	Athens		Greece	11526
307	Novartis Investigative Site	Athens		Greece	11528
308	Novartis Investigative Site	Chaidari		Greece	12461
309	Novartis Investigative Site	Thessaloniki		Greece	GR 54636
310	Novartis Investigative Site	Balatonfured		Hungary	H-8231
311	Novartis Investigative Site	Budapest		Hungary	1027
312	Novartis Investigative Site	Budapest		Hungary	1043
313	Novartis Investigative Site	Budapest		Hungary	1085
314	Novartis Investigative Site	Budapest		Hungary	1106
315	Novartis Investigative Site	Budapest		Hungary	1125
316	Novartis Investigative Site	Budapest		Hungary	1134
317	Novartis Investigative Site	Budapest		Hungary	1145
318	Novartis Investigative Site	Budapest		Hungary	H 1096
319	Novartis Investigative Site	Cegled		Hungary	2700
320	Novartis Investigative Site	Debrecen		Hungary	4032
321	Novartis Investigative Site	Kaposvar		Hungary	7400
322	Novartis Investigative Site	Mateszalka		Hungary	4700
323	Novartis Investigative Site	Pecs		Hungary	7624
324	Novartis Investigative Site	Szekesfehervar		Hungary	H-8000
325	Novartis Investigative Site	Szombathely		Hungary	9700
326	Novartis Investigative Site	Zalaegerszeg		Hungary	8900
327	Novartis Investigative Site	Dublin 24		Ireland
328	Novartis Investigative Site	Dublin 4		Ireland	4
329	Novartis Investigative Site	Dublin 7		Ireland
330	Novartis Investigative Site	Galway		Ireland
331	Novartis Investigative Site	Ashkelon		Israel	78278
332	Novartis Investigative Site	Hadera		Israel	38100
333	Novartis Investigative Site	Haifa		Israel	3525408
334	Novartis Investigative Site	Jerusalem		Israel	91120
335	Novartis Investigative Site	Jerusalem		Israel	91240
336	Novartis Investigative Site	Lower Galilee		Israel	15208
337	Novartis Investigative Site	Nahariya		Israel	22100
338	Novartis Investigative Site	Petach Tikva		Israel	49100
339	Novartis Investigative Site	Rehovot		Israel	76100
340	Novartis Investigative Site	Sefad		Israel	13100
341	Novartis Investigative Site	Tel Aviv		Israel	64239
342	Novartis Investigative Site	Tel Giborim, Holon		Israel	58100
343	Novartis Investigative Site	Cortona	AR	Italy	52044
344	Novartis Investigative Site	Bergamo	BG	Italy	24127
345	Novartis Investigative Site	Brescia	BS	Italy	25123
346	Novartis Investigative Site	Gavardo	BS	Italy	25085
347	Novartis Investigative Site	Bolzano	BZ	Italy	39100
348	Novartis Investigative Site	Cremona	CR	Italy	26100
349	Novartis Investigative Site	Cona	FE	Italy	44100
350	Novartis Investigative Site	Foggia	FG	Italy	71100
351	Novartis Investigative Site	Firenze	FI	Italy	50134
352	Novartis Investigative Site	Pozzilli	IS	Italy	86077
353	Novartis Investigative Site	Monza	MB	Italy	20900
354	Novartis Investigative Site	Milano	MI	Italy	20122
355	Novartis Investigative Site	Milano	MI	Italy	20162
356	Novartis Investigative Site	Vimercate	MI	Italy	200059
357	Novartis Investigative Site	Modena	MO	Italy	41100
358	Novartis Investigative Site	Perugia	PG	Italy	06129
359	Novartis Investigative Site	Pisa	PI	Italy	56124
360	Novartis Investigative Site	Parma	PR	Italy	43100
361	Novartis Investigative Site	Pavia	PV	Italy	27100
362	Novartis Investigative Site	Albano Laziale	RM	Italy	00041
363	Novartis Investigative Site	Roma	RM	Italy	00161
364	Novartis Investigative Site	Rimini	RN	Italy	47900
365	Novartis Investigative Site	Torino	TO	Italy	10126
366	Novartis Investigative Site	Trieste	TS	Italy	34149
367	Novartis Investigative Site	Udine	UD	Italy	33100
368	Novartis Investigative Site	Novara		Italy	28100
369	Novartis Investigative Site	Mexico	Distrito Federal	Mexico	14080
370	Novartis Investigative Site	Guadalajara	Jalisco	Mexico	44280
371	Novartis Investigative Site	San Luis Potosi	San Luis Potosí	Mexico	78240
372	Novartis Investigative Site	Culiacán	Sinaloa	Mexico	80230
373	Novartis Investigative Site	San Luis Potosi		Mexico	78200
374	Novartis Investigative Site	Sneek	The Netherlands	Netherlands	8601 ZR
375	Novartis Investigative Site	Almelo		Netherlands	7609 PP
376	Novartis Investigative Site	Amersfoort		Netherlands	3813 TZ
377	Novartis Investigative Site	Amsterdam		Netherlands	1105 AZ
378	Novartis Investigative Site	Arnhem		Netherlands	6815 AD
379	Novartis Investigative Site	Deventer		Netherlands	7416 SE
380	Novartis Investigative Site	Gorinchem		Netherlands	4204 AA
381	Novartis Investigative Site	Groningen		Netherlands
382	Novartis Investigative Site	Haarlem		Netherlands	2035 RC
383	Novartis Investigative Site	Hardenberg		Netherlands	7770 AA
384	Novartis Investigative Site	Maastricht		Netherlands	6229 HX
385	Novartis Investigative Site	Nijmegen		Netherlands
386	Novartis Investigative Site	Rotterdam		Netherlands	3045 PM
387	Novartis Investigative Site	Venlo		Netherlands	5912 BL
388	Novartis Investigative Site	Zutphen		Netherlands	7207 AE
389	Novartis Investigative Site	Stavanger		Norway	4068
390	Novartis Investigative Site	Cercado De Lima	Lima	Peru	01
391	Novartis Investigative Site	Krakow	POL	Poland	31-121
392	Novartis Investigative Site	Bialystok		Poland	15-276
393	Novartis Investigative Site	Grodzisk Mazowiecki		Poland	05-825
394	Novartis Investigative Site	Klodzko		Poland	57-300
395	Novartis Investigative Site	Krakow		Poland	31 501
396	Novartis Investigative Site	Krakow		Poland	31-202
397	Novartis Investigative Site	Krakow		Poland	31202
398	Novartis Investigative Site	Lodz		Poland	91-425
399	Novartis Investigative Site	Lódz		Poland	91-347
400	Novartis Investigative Site	Olawa		Poland	55-200
401	Novartis Investigative Site	Pulawy		Poland	24100
402	Novartis Investigative Site	Warszawa		Poland	01-211
403	Novartis Investigative Site	Warszawa		Poland	02-097
404	Novartis Investigative Site	Warszawa		Poland	04-628
405	Novartis Investigative Site	Wloclawek		Poland	87-800
406	Novartis Investigative Site	Wroclaw		Poland	50-981
407	Novartis Investigative Site	Carnaxide - Linda-A-Velha	Lisboa	Portugal	2790-134
408	Novartis Investigative Site	Vila Real	Portuigal	Portugal	5000-508
409	Novartis Investigative Site	Amadora		Portugal	2720-276
410	Novartis Investigative Site	Coimbra		Portugal	3000-075
411	Novartis Investigative Site	Covilha		Portugal	6200-251
412	Novartis Investigative Site	Lisboa		Portugal	1449-005
413	Novartis Investigative Site	Lisboa		Portugal	1649-035
414	Novartis Investigative Site	Penafiel		Portugal	4564-007
415	Novartis Investigative Site	Porto		Portugal	4200-319
416	Novartis Investigative Site	Viana Do Castelo		Portugal	4901858
417	Novartis Investigative Site	Vila Nova de Gaia		Portugal	4434-502
418	Novartis Investigative Site	Mayaguez		Puerto Rico	00680
419	Novartis Investigative Site	Targu Mures	Mures	Romania	540136
420	Novartis Investigative Site	Tg. Mures	Mures	Romania	540136
421	Novartis Investigative Site	Arad		Romania	310158
422	Novartis Investigative Site	Baia Mare		Romania	430031
423	Novartis Investigative Site	Braila		Romania	810249
424	Novartis Investigative Site	Brasov		Romania	300 326
425	Novartis Investigative Site	Bucharest		Romania	020125
426	Novartis Investigative Site	Bucharest		Romania	021659
427	Novartis Investigative Site	Bucharest		Romania	041915
428	Novartis Investigative Site	Bucharest		Romania	050659
429	Novartis Investigative Site	Bucuresti		Romania	014461
430	Novartis Investigative Site	Bucuresti		Romania	022328
431	Novartis Investigative Site	Craiova		Romania	200642
432	Novartis Investigative Site	Oradea		Romania	410169
433	Novartis Investigative Site	Pitesti		Romania	110084
434	Novartis Investigative Site	Timisoara		Romania	300 079
435	Novartis Investigative Site	Timisoara		Romania	300041
436	Novartis Investigative Site	Timisoara		Romania	300310
437	Novartis Investigative Site	Timisoara		Romania	300736
438	Novartis Investigative Site	Barnaul		Russian Federation	656038
439	Novartis Investigative Site	Ekaterinburg		Russian Federation	620028
440	Novartis Investigative Site	Ivanovo		Russian Federation	153012
441	Novartis Investigative Site	Kemerovo		Russian Federation	650002
442	Novartis Investigative Site	Kemerovo		Russian Federation	650014
443	Novartis Investigative Site	Kirov		Russian Federation	610014
444	Novartis Investigative Site	Moscow		Russian Federation	111539
445	Novartis Investigative Site	Moscow		Russian Federation	117292
446	Novartis Investigative Site	Moscow		Russian Federation	121309
447	Novartis Investigative Site	Moscow		Russian Federation	121552
448	Novartis Investigative Site	Moscow		Russian Federation	127476
449	Novartis Investigative Site	Moscow		Russian Federation	127644
450	Novartis Investigative Site	Novosibirsk		Russian Federation	630008
451	Novartis Investigative Site	S.-Petersburg		Russian Federation	192242
452	Novartis Investigative Site	S.-Petersburg		Russian Federation	196247
453	Novartis Investigative Site	S.-Petersburg		Russian Federation	198205
454	Novartis Investigative Site	Saint Petersburg		Russian Federation	195067
455	Novartis Investigative Site	Saint Petersburg		Russian Federation	199106
456	Novartis Investigative Site	Saint-Petersburg		Russian Federation	194044
457	Novartis Investigative Site	Samara		Russian Federation	443070
458	Novartis Investigative Site	Saratov		Russian Federation	410012
459	Novartis Investigative Site	St Petersburg		Russian Federation	196601
460	Novartis Investigative Site	St. Petersburg		Russian Federation	190013
461	Novartis Investigative Site	Tomsk		Russian Federation	634012
462	Novartis Investigative Site	Vladimir		Russian Federation	600020
463	Novartis Investigative Site	Voronezh		Russian Federation	394065
464	Novartis Investigative Site	Yaroslavl		Russian Federation	150030
465	Novartis Investigative Site	Kosice	Slovak Republic	Slovakia	040 15
466	Novartis Investigative Site	Liptovsky Mikulas	Slovak Republic	Slovakia	031 23
467	Novartis Investigative Site	Topolcany	Slovak Republic	Slovakia	95520
468	Novartis Investigative Site	Banska Bystrica		Slovakia	97401
469	Novartis Investigative Site	Bratislava		Slovakia	813 69
470	Novartis Investigative Site	Bratislava		Slovakia	826 06
471	Novartis Investigative Site	Bratislava		Slovakia	833 48
472	Novartis Investigative Site	Bratislava		Slovakia	851 07
473	Novartis Investigative Site	Lucenec		Slovakia	98439
474	Novartis Investigative Site	Martin		Slovakia	036 59
475	Novartis Investigative Site	Nitra		Slovakia	949 01
476	Novartis Investigative Site	Nove Zamky		Slovakia	940 34
477	Novartis Investigative Site	Presov		Slovakia	081 01
478	Novartis Investigative Site	Rimavska Sobota		Slovakia	97912
479	Novartis Investigative Site	Trnava		Slovakia	917 75
480	Novartis Investigative Site	Bloemfontein	Free State	South Africa	9301
481	Novartis Investigative Site	Durban		South Africa	4001
482	Novartis Investigative Site	Johannesburg		South Africa	2157
483	Novartis Investigative Site	Johannesburg		South Africa	2193
484	Novartis Investigative Site	Umhlanga		South Africa	4320
485	Novartis Investigative Site	Western Cape		South Africa	7130
486	Novartis Investigative Site	Cordoba	Andalucia	Spain	14004
487	Novartis Investigative Site	Malaga	Andalucia	Spain	29010
488	Novartis Investigative Site	Marbella	Andalucia	Spain	29600
489	Novartis Investigative Site	Sanlucar de Barrameda	Andalucia	Spain	11540
490	Novartis Investigative Site	Sevilla	Andalucia	Spain	41014
491	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona	Spain	08907
492	Novartis Investigative Site	Sant Joan Despi	Barcelona	Spain	08970
493	Novartis Investigative Site	Villamartin	Cadiz	Spain	11650
494	Novartis Investigative Site	Leon	Castilla Y Leon	Spain	24071
495	Novartis Investigative Site	Badalona	Catalunya	Spain	08916
496	Novartis Investigative Site	Barcelona	Catalunya	Spain	08003
497	Novartis Investigative Site	Barcelona	Catalunya	Spain	08036
498	Novartis Investigative Site	Alicante	Comunidad Valenciana	Spain	03010
499	Novartis Investigative Site	Valencia	Comunidad Valenciana	Spain	46010
500	Novartis Investigative Site	Valencia	Comunidad Valenciana	Spain	46026
501	Novartis Investigative Site	A Coruna	Galicia	Spain	15006
502	Novartis Investigative Site	La Coruna	Galicia	Spain	15006
503	Novartis Investigative Site	Getafe	Madrid	Spain	28905
504	Novartis Investigative Site	Majadahonda	Madrid	Spain	28222
505	Novartis Investigative Site	El Palmar	Murcia	Spain	30120
506	Novartis Investigative Site	Barcelona		Spain	08041
507	Novartis Investigative Site	Madrid		Spain	28007
508	Novartis Investigative Site	Madrid		Spain	28040
509	Novartis Investigative Site	Joenkoeping		Sweden	551 85
510	Novartis Investigative Site	Linkoping		Sweden	581 85
511	Novartis Investigative Site	Molndal		Sweden	431 80
512	Novartis Investigative Site	Stockholm		Sweden	17176
513	Novartis Investigative Site	Uppsala		Sweden	SE-751 85
514	Novartis Investigative Site	Basel		Switzerland	4031
515	Novartis Investigative Site	Bern		Switzerland	3010
516	Novartis Investigative Site	Lausanne		Switzerland	1011
517	Novartis Investigative Site	St. Gallen		Switzerland	9007
518	Novartis Investigative Site	Ankara		Turkey	06100
519	Novartis Investigative Site	Haydarpasa/Istanbul		Turkey	34668
520	Novartis Investigative Site	Istanbul		Turkey	34304
521	Novartis Investigative Site	Kocaeli		Turkey	41380
522	Novartis Investigative Site	Mersin		Turkey	33079
523	Novartis Investigative Site	Pendik / Istanbul		Turkey	34899
524	Novartis Investigative Site	Sivas		Turkey	58140
525	Novartis Investigative Site	High Wycombe	Buckinghamshire	United Kingdom	HP11 2TT
526	Novartis Investigative Site	Torquay	Devon	United Kingdom	TQ2 7AA
527	Novartis Investigative Site	Basingstoke	Hampshire	United Kingdom	RG24 9NA
528	Novartis Investigative Site	Nottingham	Hampshire	United Kingdom	NG7 2UH
529	Novartis Investigative Site	Blackburn	Lancashire	United Kingdom	BB2 3HH
530	Novartis Investigative Site	Hardwick,	Stockton On Tees	United Kingdom	TS19 8PE
531	Novartis Investigative Site	Dudley	West Midlands	United Kingdom	DY1 2HQ
532	Novartis Investigative Site	Blackpool		United Kingdom	FY3 8NR
533	Novartis Investigative Site	Edinburgh		United Kingdom	EH16 4SA
534	Novartis Investigative Site	Glasgow		United Kingdom	G51 4TF
535	Novartis Investigative Site	Kettering		United Kingdom	NN16 8UZ
536	Novartis Investigative Site	Leicester		United Kingdom	LE3 9QP
537	Novartis Investigative Site	Liverpool		United Kingdom	L7 8XP
538	Novartis Investigative Site	Liverpool		United Kingdom	L9 7AL
539	Novartis Investigative Site	London		United Kingdom	SE5 9RS
540	Novartis Investigative Site	Manchester		United Kingdom	M13 9WL
541	Novartis Investigative Site	Portsmouth		United Kingdom	PO6 3LY
542	Novartis Investigative Site	Swindon		United Kingdom	SN3 6BB

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01870778

Other Study ID Numbers:

CRLX030A2301
2013-001498-25

First Posted:

Jun 6, 2013

Last Update Posted:

Mar 30, 2018

Last Verified:

Mar 1, 2018

Keywords provided by Novartis Pharmaceuticals

Additional relevant MeSH terms:

Heart Failure

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	6600 participants were randomized into the trial. Only 6545 participants were eligible for analysis. Therefore, the participants flow and baseline characteristics are based on 6545 participants.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Period Title: Overall Study
STARTED	3274	3271
Safety Set	3257	3248
Full Analysis Set	3274	3271
Biomarker Analysis Set	521	510
COMPLETED	3266	3262
NOT COMPLETED	8	9

Baseline Characteristics

Arm/Group Title	Serelaxin (RLX030)	Placebo	Total
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.	Total of all reporting groups
Overall Participants	3274	3271	6545
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	73.1 (11.24)	72.8 (11.17)	73.0 (11.20)
Sex: Female, Male (Count of Participants)
Female	1296 39.6%	1341 41%	2637 40.3%
Male	1978 60.4%	1930 59%	3908 59.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	13 0.4%	18 0.6%	31 0.5%
Asian	14 0.4%	16 0.5%	30 0.5%
Native Hawaiian or Other Pacific Islander	4 0.1%	4 0.1%	8 0.1%
Black or African American	163 5%	171 5.2%	334 5.1%
White	3017 92.2%	2999 91.7%	6016 91.9%
More than one race	46 1.4%	46 1.4%	92 1.4%
Unknown or Not Reported	17 0.5%	17 0.5%	34 0.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180
Description	The percentage of participants with an adjudicated CV death through day 180 was assessed.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	3274	3271
Number [Percentage of participants]	8.7 0.3%	8.9 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.3857
	Comments	Adjusted alpha p-value based on multiple testing procedure.
	Method	Log Rank
	Comments	One-sided p-value

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95% 0.83 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5
Description	The percentage of participants with WHF through day 5 was assessed.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	3274	3271
Number [Percentage of participants]	6.9 0.2%	7.7 0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0968
	Comments	Adjusted p-value based on multiple testing procedure
	Method	Gehan's generalized Wilcoxon test
	Comments	One-sided p-value

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95% 0.75 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants With All-cause Death Through Day 180
Description	The percentage of participants with all-cause death through day 180 was assessed.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	3274	3271
Number [Percentage of participants]	11.2 0.3%	11.9 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.3890
	Comments
	Method	Log Rank
	Comments	2-sided p-value

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95% 0.81 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization
Description	Length of stay was defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day.
Time Frame	180 days (Participants still in the hospital at Day 60 were censored at Day 60)

Outcome Measure Data

Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	3274	3271
Mean (Standard Deviation) [days]	9.362 (9.3581)	9.545 (9.6739)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.2204
	Comments	Based on multiple testing procedure
	Method	Wilcoxon rank sum test
	Comments	One-sided p-value

5. Secondary Outcome

Title	Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization
Description	The percentage of participants with adjudicated CV death or adjudicated re-hospitalization through day 180 was assessed.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	3274	3271
Number [Percentage of participants]	24.3 0.7%	24.9 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.2744
	Comments	Adjusted p-value based on multiple testing procedure
	Method	Log Rank
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95% 0.88 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
Description	Length of stay was defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day.
Time Frame	180 days (Patients still in the hospital at Day 60 were censored at Day 60)

Outcome Measure Data

Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	3274	3271
Mean (Standard Deviation) [days]	3.8 (8.29)	4.1 (8.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.2103
	Comments
	Method	Wilcoxon rank sum test
	Comments	2-sided p-value

7. Secondary Outcome

Title	Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
Description	The percentage of participants with first improvement since baseline in congestive signs and symptoms was assessed. The signs and symptoms included exertional dyspnea, orthopnea, rales, jugular venous pressure and peripheral edema/pre-sacral edema.
Time Frame	From baseline to Day 5

Outcome Measure Data

Analysis Population Description
The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was considered for the analysis. For each symptom, only participants with observed baseline signs and symptoms and non-missing baseline and post baseline signs and symptoms were analyzed.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	3044	3039
Exertional dyspnea	94.1 2.9%	92.6 2.8%
Orthopnea	92.9 2.8%	91.2 2.8%
Rales	94.1 2.9%	93.7 2.9%
Jugular venous pressure	90.4 2.8%	88.0 2.7%
Peripheral edema, pre-sacral edema	91.6 2.8%	90.7 2.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Exertional dyspnea
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0050
	Comments
	Method	Log Rank
	Comments	2-sided p-value

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95% 1.02 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Orthopnea
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0051
	Comments
	Method	Log Rank
	Comments	2-sided p-value

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95% 1.02 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Rales
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.9962
	Comments
	Method	Log Rank
	Comments	2-sided p-value

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95% 0.95 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Jugular venous pressure
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0196
	Comments
	Method	Log Rank
	Comments	2-sided p-value

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95% 1.01 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Peripheral edema, pre-sacral edema
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.2158
	Comments
	Method	Log Rank
	Comments	2-sided p-value

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95% 0.98 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in hsTroponin T Biomarker
Description	Blood samples were collected to assess the change from baseline in hsTroponin T. The geometric least square mean (LSM) of the ratio of the post-baseline value to the baseline value is presented.
Time Frame	Baseline, Day 2, Day 5 and Day 14

Outcome Measure Data

Analysis Population Description
Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	521	510
Day 2	0.9808	1.0432
Day 5	0.9589	1.0678
Day 14	0.7813	0.8611

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 2
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0209
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.9401
	Confidence Interval	(2-Sided) 95% 0.8921 to 0.9907
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 5
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0034
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.8980
	Confidence Interval	(2-Sided) 95% 0.8358 to 0.9649
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 14
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0209
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.9074
	Confidence Interval	(2-Sided) 95% 0.8355 to 0.9854
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline in NT-proBNP Biomarker
Description	Blood samples were collected to assess the change from baseline in NT-proBNP. The ratio of the post-baseline value to the baseline value is presented.
Time Frame	Baseline, Day 2, Day 5 and Day 14

Outcome Measure Data

Analysis Population Description
Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	521	510
Day 2	0.4902	0.5702
Day 5	0.4249	0.4454
Day 14	0.4265	0.4469

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 2
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0007
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.8597
	Confidence Interval	(2-Sided) 95% 0.7876 to 0.9385
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 5
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.3709
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.9539
	Confidence Interval	(2-Sided) 95% 0.8600 to 1.0579
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 14
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.3893
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.9543
	Confidence Interval	(2-Sided) 95% 0.8578 to 1.0617
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Cystatin C Biomarker
Description	Blood samples were collected to assess the change from baseline in Cystatin C. The ratio of the post-baseline value to the baseline value is presented.
Time Frame	Baseline, Day 2, Day 5 and Day 14

Outcome Measure Data

Analysis Population Description
Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.

Arm/Group Title	Serelaxin (RLX030)	Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.	Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Measure Participants	521	510
Day 2	1.0261	1.0648
Day 5	1.1171	1.1259
Day 14	1.1186	1.1342

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 2
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.9637
	Confidence Interval	(2-Sided) 95% 0.9447 to 0.9830
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 5
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.5361
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.9922
	Confidence Interval	(2-Sided) 95% 0.9677 to 1.0172
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Serelaxin (RLX030), Placebo
	Comments	Day 14
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.3750
	Comments
	Method	Repeated measures model
	Comments

Method of Estimation	Estimation Parameter	Ratio of RLX030 to placebo
	Estimated Value	0.9863
	Confidence Interval	(2-Sided) 95% 0.9567 to 1.0169
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

	Serelaxin (RLX030)		Placebo
Time Frame	up to 180 days
Adverse Event Reporting Description

Arm/Group Title	Serelaxin (RLX030)		Placebo
Arm/Group Description	Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.		Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	363/3257 (11.1%)		386/3248 (11.9%)
Serious Adverse Events
	Serelaxin (RLX030)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	412/3257 (12.6%)		424/3248 (13.1%)
Blood and lymphatic system disorders
Anaemia	7/3257 (0.2%)		7/3248 (0.2%)
Anaemia macrocytic	1/3257 (0%)		0/3248 (0%)
Haemorrhagic anaemia	0/3257 (0%)		1/3248 (0%)
Heparin-induced thrombocytopenia	0/3257 (0%)		1/3248 (0%)
Leukocytosis	0/3257 (0%)		1/3248 (0%)
Leukopenia	1/3257 (0%)		0/3248 (0%)
Lymphadenopathy	0/3257 (0%)		1/3248 (0%)
Cardiac disorders
Acute coronary syndrome	1/3257 (0%)		3/3248 (0.1%)
Acute left ventricular failure	1/3257 (0%)		0/3248 (0%)
Acute myocardial infarction	14/3257 (0.4%)		12/3248 (0.4%)
Angina pectoris	1/3257 (0%)		7/3248 (0.2%)
Angina unstable	2/3257 (0.1%)		2/3248 (0.1%)
Aortic valve incompetence	1/3257 (0%)		2/3248 (0.1%)
Aortic valve stenosis	4/3257 (0.1%)		9/3248 (0.3%)
Arrhythmia	0/3257 (0%)		2/3248 (0.1%)
Arteriosclerosis coronary artery	2/3257 (0.1%)		0/3248 (0%)
Atrial fibrillation	10/3257 (0.3%)		13/3248 (0.4%)
Atrial flutter	2/3257 (0.1%)		2/3248 (0.1%)
Atrial thrombosis	0/3257 (0%)		1/3248 (0%)
Atrioventricular block	1/3257 (0%)		0/3248 (0%)
Atrioventricular block complete	5/3257 (0.2%)		2/3248 (0.1%)
Atrioventricular block second degree	0/3257 (0%)		1/3248 (0%)
Atrioventricular dissociation	1/3257 (0%)		0/3248 (0%)
Bradyarrhythmia	1/3257 (0%)		1/3248 (0%)
Bradycardia	4/3257 (0.1%)		4/3248 (0.1%)
Cardiac arrest	4/3257 (0.1%)		9/3248 (0.3%)
Cardiac failure	62/3257 (1.9%)		68/3248 (2.1%)
Cardiac failure acute	14/3257 (0.4%)		8/3248 (0.2%)
Cardiac failure chronic	2/3257 (0.1%)		3/3248 (0.1%)
Cardiac failure congestive	12/3257 (0.4%)		9/3248 (0.3%)
Cardio-respiratory arrest	2/3257 (0.1%)		2/3248 (0.1%)
Cardiogenic shock	5/3257 (0.2%)		6/3248 (0.2%)
Cardiopulmonary failure	1/3257 (0%)		0/3248 (0%)
Cardiorenal syndrome	1/3257 (0%)		2/3248 (0.1%)
Chordae tendinae rupture	2/3257 (0.1%)		1/3248 (0%)
Congestive cardiomyopathy	0/3257 (0%)		2/3248 (0.1%)
Coronary artery disease	17/3257 (0.5%)		12/3248 (0.4%)
Coronary artery occlusion	1/3257 (0%)		1/3248 (0%)
Coronary artery perforation	1/3257 (0%)		0/3248 (0%)
Coronary artery stenosis	5/3257 (0.2%)		2/3248 (0.1%)
Defect conduction intraventricular	0/3257 (0%)		1/3248 (0%)
Ischaemic cardiomyopathy	1/3257 (0%)		0/3248 (0%)
Left ventricular dysfunction	2/3257 (0.1%)		0/3248 (0%)
Mitral valve incompetence	5/3257 (0.2%)		5/3248 (0.2%)
Mitral valve stenosis	0/3257 (0%)		1/3248 (0%)
Myocardial infarction	3/3257 (0.1%)		4/3248 (0.1%)
Myocardial ischaemia	2/3257 (0.1%)		3/3248 (0.1%)
Pericarditis	0/3257 (0%)		1/3248 (0%)
Sinus bradycardia	1/3257 (0%)		2/3248 (0.1%)
Sinus node dysfunction	1/3257 (0%)		2/3248 (0.1%)
Supraventricular tachycardia	1/3257 (0%)		2/3248 (0.1%)
Tachyarrhythmia	0/3257 (0%)		1/3248 (0%)
Tachycardia	1/3257 (0%)		0/3248 (0%)
Torsade de pointes	1/3257 (0%)		0/3248 (0%)
Ventricular arrhythmia	1/3257 (0%)		1/3248 (0%)
Ventricular fibrillation	4/3257 (0.1%)		6/3248 (0.2%)
Ventricular tachycardia	14/3257 (0.4%)		11/3248 (0.3%)
Endocrine disorders
Hyperthyroidism	0/3257 (0%)		1/3248 (0%)
Gastrointestinal disorders
Abdominal pain	2/3257 (0.1%)		0/3248 (0%)
Ascites	1/3257 (0%)		0/3248 (0%)
Colitis	0/3257 (0%)		1/3248 (0%)
Diarrhoea	1/3257 (0%)		0/3248 (0%)
Duodenal ulcer haemorrhage	1/3257 (0%)		1/3248 (0%)
Dyspepsia	0/3257 (0%)		1/3248 (0%)
Enterocolitis	0/3257 (0%)		1/3248 (0%)
Gastritis	1/3257 (0%)		0/3248 (0%)
Gastritis erosive	1/3257 (0%)		0/3248 (0%)
Gastroduodenal ulcer	1/3257 (0%)		0/3248 (0%)
Gastrointestinal haemorrhage	2/3257 (0.1%)		2/3248 (0.1%)
Haematochezia	1/3257 (0%)		0/3248 (0%)
Ileus	2/3257 (0.1%)		0/3248 (0%)
Ileus paralytic	0/3257 (0%)		1/3248 (0%)
Inguinal hernia	1/3257 (0%)		1/3248 (0%)
Intestinal stenosis	0/3257 (0%)		1/3248 (0%)
Large intestinal haemorrhage	0/3257 (0%)		1/3248 (0%)
Large intestine polyp	1/3257 (0%)		0/3248 (0%)
Melaena	1/3257 (0%)		0/3248 (0%)
Pancreatitis	0/3257 (0%)		1/3248 (0%)
Peritoneal haemorrhage	0/3257 (0%)		1/3248 (0%)
Rectal haemorrhage	1/3257 (0%)		1/3248 (0%)
Retroperitoneal haemorrhage	1/3257 (0%)		0/3248 (0%)
Small intestinal obstruction	0/3257 (0%)		1/3248 (0%)
Subileus	0/3257 (0%)		1/3248 (0%)
Vomiting	1/3257 (0%)		0/3248 (0%)
General disorders
Asthenia	0/3257 (0%)		1/3248 (0%)
Cardiac death	0/3257 (0%)		2/3248 (0.1%)
Drug effect increased	1/3257 (0%)		0/3248 (0%)
Extravasation	0/3257 (0%)		1/3248 (0%)
Fatigue	0/3257 (0%)		1/3248 (0%)
General physical health deterioration	1/3257 (0%)		0/3248 (0%)
Inflammation	1/3257 (0%)		0/3248 (0%)
Infusion site phlebitis	0/3257 (0%)		1/3248 (0%)
Multiple organ dysfunction syndrome	4/3257 (0.1%)		1/3248 (0%)
Non-cardiac chest pain	2/3257 (0.1%)		0/3248 (0%)
Pyrexia	0/3257 (0%)		1/3248 (0%)
Sudden cardiac death	3/3257 (0.1%)		6/3248 (0.2%)
Sudden death	0/3257 (0%)		1/3248 (0%)
Vascular stent occlusion	0/3257 (0%)		1/3248 (0%)
Hepatobiliary disorders
Alcoholic liver disease	0/3257 (0%)		1/3248 (0%)
Drug-induced liver injury	0/3257 (0%)		1/3248 (0%)
Hepatic congestion	1/3257 (0%)		0/3248 (0%)
Hepatic failure	2/3257 (0.1%)		3/3248 (0.1%)
Hepatic function abnormal	1/3257 (0%)		0/3248 (0%)
Hepatocellular injury	2/3257 (0.1%)		1/3248 (0%)
Hyperbilirubinaemia	0/3257 (0%)		1/3248 (0%)
Jaundice	1/3257 (0%)		0/3248 (0%)
Liver injury	1/3257 (0%)		1/3248 (0%)
Immune system disorders
Hypersensitivity	1/3257 (0%)		0/3248 (0%)
Infections and infestations
Abdominal abscess	1/3257 (0%)		0/3248 (0%)
Appendicitis	0/3257 (0%)		1/3248 (0%)
Arthritis bacterial	1/3257 (0%)		0/3248 (0%)
Aspergilloma	0/3257 (0%)		1/3248 (0%)
Bacteraemia	0/3257 (0%)		1/3248 (0%)
Bronchitis	9/3257 (0.3%)		4/3248 (0.1%)
Cellulitis	0/3257 (0%)		1/3248 (0%)
Cholecystitis infective	1/3257 (0%)		0/3248 (0%)
Chronic hepatitis B	1/3257 (0%)		0/3248 (0%)
Clostridium difficile infection	1/3257 (0%)		1/3248 (0%)
Cystitis	3/3257 (0.1%)		1/3248 (0%)
Cystitis bacterial	0/3257 (0%)		1/3248 (0%)
Device related infection	0/3257 (0%)		1/3248 (0%)
Diverticulitis	0/3257 (0%)		1/3248 (0%)
Enterocolitis bacterial	0/3257 (0%)		1/3248 (0%)
Erysipelas	1/3257 (0%)		0/3248 (0%)
Gastroenteritis	2/3257 (0.1%)		2/3248 (0.1%)
Gastroenteritis clostridial	0/3257 (0%)		1/3248 (0%)
Influenza	1/3257 (0%)		0/3248 (0%)
Intervertebral discitis	0/3257 (0%)		1/3248 (0%)
Lower respiratory tract infection	2/3257 (0.1%)		0/3248 (0%)
Nasopharyngitis	0/3257 (0%)		1/3248 (0%)
Nosocomial infection	1/3257 (0%)		0/3248 (0%)
Orchitis	0/3257 (0%)		1/3248 (0%)
Pharyngitis	1/3257 (0%)		0/3248 (0%)
Pneumococcal sepsis	1/3257 (0%)		0/3248 (0%)
Pneumonia	34/3257 (1%)		32/3248 (1%)
Pneumonia streptococcal	1/3257 (0%)		0/3248 (0%)
Pulmonary sepsis	1/3257 (0%)		1/3248 (0%)
Pyelonephritis	0/3257 (0%)		1/3248 (0%)
Respiratory tract infection	0/3257 (0%)		1/3248 (0%)
Sepsis	6/3257 (0.2%)		8/3248 (0.2%)
Septic shock	4/3257 (0.1%)		2/3248 (0.1%)
Staphylococcal bacteraemia	2/3257 (0.1%)		3/3248 (0.1%)
Staphylococcal infection	0/3257 (0%)		1/3248 (0%)
Streptococcal bacteraemia	1/3257 (0%)		0/3248 (0%)
Streptococcal sepsis	1/3257 (0%)		0/3248 (0%)
Urinary tract infection	13/3257 (0.4%)		5/3248 (0.2%)
Urinary tract infection pseudomonal	0/3257 (0%)		1/3248 (0%)
Urosepsis	1/3257 (0%)		3/3248 (0.1%)
Injury, poisoning and procedural complications
Aortic restenosis	1/3257 (0%)		0/3248 (0%)
Cardiac valve replacement complication	0/3257 (0%)		1/3248 (0%)
Coronary artery restenosis	2/3257 (0.1%)		1/3248 (0%)
Facial bones fracture	0/3257 (0%)		1/3248 (0%)
Fall	1/3257 (0%)		0/3248 (0%)
Femoral neck fracture	2/3257 (0.1%)		0/3248 (0%)
Lumbar vertebral fracture	2/3257 (0.1%)		0/3248 (0%)
Post procedural myocardial infarction	1/3257 (0%)		0/3248 (0%)
Procedural complication	1/3257 (0%)		0/3248 (0%)
Procedural hypotension	1/3257 (0%)		0/3248 (0%)
Procedural pneumothorax	0/3257 (0%)		1/3248 (0%)
Rib fracture	1/3257 (0%)		0/3248 (0%)
Subdural haematoma	0/3257 (0%)		2/3248 (0.1%)
Toxicity to various agents	1/3257 (0%)		0/3248 (0%)
Vascular pseudoaneurysm	0/3257 (0%)		2/3248 (0.1%)
Investigations
Aspartate aminotransferase increased	1/3257 (0%)		0/3248 (0%)
Blood bilirubin increased	2/3257 (0.1%)		0/3248 (0%)
Blood creatinine increased	1/3257 (0%)		2/3248 (0.1%)
Blood pressure decreased	0/3257 (0%)		2/3248 (0.1%)
C-reactive protein increased	1/3257 (0%)		1/3248 (0%)
Cardiac output decreased	1/3257 (0%)		0/3248 (0%)
Ejection fraction decreased	2/3257 (0.1%)		2/3248 (0.1%)
Electrocardiogram T wave inversion	0/3257 (0%)		1/3248 (0%)
Haemoglobin decreased	0/3257 (0%)		1/3248 (0%)
Hepatic enzyme increased	3/3257 (0.1%)		1/3248 (0%)
Liver function test increased	0/3257 (0%)		1/3248 (0%)
Oxygen saturation decreased	1/3257 (0%)		0/3248 (0%)
Troponin increased	1/3257 (0%)		1/3248 (0%)
Vascular resistance pulmonary increased	1/3257 (0%)		0/3248 (0%)
Metabolism and nutrition disorders
Dehydration	3/3257 (0.1%)		1/3248 (0%)
Diabetes mellitus	0/3257 (0%)		1/3248 (0%)
Gout	1/3257 (0%)		1/3248 (0%)
Hyperkalaemia	3/3257 (0.1%)		2/3248 (0.1%)
Hypoglycaemia	1/3257 (0%)		2/3248 (0.1%)
Hypokalaemia	1/3257 (0%)		1/3248 (0%)
Hyponatraemia	1/3257 (0%)		0/3248 (0%)
Hypovolaemia	1/3257 (0%)		0/3248 (0%)
Lactic acidosis	0/3257 (0%)		1/3248 (0%)
Metabolic acidosis	1/3257 (0%)		0/3248 (0%)
Metabolic alkalosis	0/3257 (0%)		1/3248 (0%)
Type 2 diabetes mellitus	0/3257 (0%)		1/3248 (0%)
Musculoskeletal and connective tissue disorders
Facial asymmetry	0/3257 (0%)		1/3248 (0%)
Joint effusion	1/3257 (0%)		0/3248 (0%)
Muscle haemorrhage	2/3257 (0.1%)		0/3248 (0%)
Muscle spasms	1/3257 (0%)		0/3248 (0%)
Musculoskeletal chest pain	1/3257 (0%)		0/3248 (0%)
Myositis	1/3257 (0%)		0/3248 (0%)
Pain in extremity	0/3257 (0%)		1/3248 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma	1/3257 (0%)		0/3248 (0%)
Breast cancer	0/3257 (0%)		1/3248 (0%)
Colon neoplasm	1/3257 (0%)		0/3248 (0%)
Colorectal adenocarcinoma	0/3257 (0%)		1/3248 (0%)
Gastric cancer	0/3257 (0%)		1/3248 (0%)
Lung adenocarcinoma	1/3257 (0%)		0/3248 (0%)
Lung adenocarcinoma metastatic	0/3257 (0%)		1/3248 (0%)
Lung neoplasm malignant	1/3257 (0%)		2/3248 (0.1%)
Mediastinum neoplasm	0/3257 (0%)		1/3248 (0%)
Mesothelioma	0/3257 (0%)		1/3248 (0%)
Metastases to liver	0/3257 (0%)		1/3248 (0%)
Metastases to lung	0/3257 (0%)		1/3248 (0%)
Metastatic gastric cancer	0/3257 (0%)		1/3248 (0%)
Myelodysplastic syndrome	1/3257 (0%)		0/3248 (0%)
Ovarian neoplasm	0/3257 (0%)		1/3248 (0%)
Prostate cancer	1/3257 (0%)		0/3248 (0%)
Renal neoplasm	0/3257 (0%)		1/3248 (0%)
Small cell lung cancer	0/3257 (0%)		1/3248 (0%)
Waldenstrom's macroglobulinaemia	1/3257 (0%)		0/3248 (0%)
Nervous system disorders
Altered state of consciousness	1/3257 (0%)		0/3248 (0%)
Aphasia	1/3257 (0%)		1/3248 (0%)
Brain stem stroke	0/3257 (0%)		1/3248 (0%)
Carotid artery stenosis	0/3257 (0%)		1/3248 (0%)
Carotid sinus syndrome	1/3257 (0%)		1/3248 (0%)
Cerebral artery embolism	0/3257 (0%)		1/3248 (0%)
Cerebral infarction	1/3257 (0%)		1/3248 (0%)
Cerebrovascular accident	2/3257 (0.1%)		3/3248 (0.1%)
Cognitive disorder	0/3257 (0%)		1/3248 (0%)
Dementia	0/3257 (0%)		1/3248 (0%)
Dizziness	1/3257 (0%)		1/3248 (0%)
Embolic stroke	1/3257 (0%)		1/3248 (0%)
Epilepsy	1/3257 (0%)		0/3248 (0%)
Haemorrhage intracranial	0/3257 (0%)		1/3248 (0%)
Hemiparesis	0/3257 (0%)		1/3248 (0%)
Hypercapnic coma	0/3257 (0%)		1/3248 (0%)
Ischaemic cerebral infarction	1/3257 (0%)		0/3248 (0%)
Ischaemic stroke	11/3257 (0.3%)		16/3248 (0.5%)
Loss of consciousness	1/3257 (0%)		0/3248 (0%)
Muscle contractions involuntary	1/3257 (0%)		0/3248 (0%)
Neuropathy peripheral	1/3257 (0%)		0/3248 (0%)
Presyncope	2/3257 (0.1%)		0/3248 (0%)
Radiculopathy	1/3257 (0%)		0/3248 (0%)
Seizure	2/3257 (0.1%)		0/3248 (0%)
Somnolence	1/3257 (0%)		1/3248 (0%)
Syncope	5/3257 (0.2%)		3/3248 (0.1%)
Transient ischaemic attack	6/3257 (0.2%)		1/3248 (0%)
Vascular encephalopathy	1/3257 (0%)		0/3248 (0%)
Product Issues
Device battery issue	1/3257 (0%)		0/3248 (0%)
Device leakage	1/3257 (0%)		0/3248 (0%)
Device malfunction	0/3257 (0%)		1/3248 (0%)
Psychiatric disorders
Acute psychosis	0/3257 (0%)		1/3248 (0%)
Confusional state	2/3257 (0.1%)		1/3248 (0%)
Delirium	2/3257 (0.1%)		2/3248 (0.1%)
Delirium tremens	1/3257 (0%)		0/3248 (0%)
Suicidal ideation	0/3257 (0%)		1/3248 (0%)
Renal and urinary disorders
Acute kidney injury	20/3257 (0.6%)		25/3248 (0.8%)
Anuria	2/3257 (0.1%)		0/3248 (0%)
Azotaemia	1/3257 (0%)		0/3248 (0%)
Chronic kidney disease	4/3257 (0.1%)		3/3248 (0.1%)
Haematuria	1/3257 (0%)		1/3248 (0%)
Nephropathy toxic	0/3257 (0%)		6/3248 (0.2%)
Nephrotic syndrome	1/3257 (0%)		1/3248 (0%)
Oliguria	1/3257 (0%)		1/3248 (0%)
Prerenal failure	1/3257 (0%)		0/3248 (0%)
Renal artery stenosis	0/3257 (0%)		1/3248 (0%)
Renal failure	10/3257 (0.3%)		16/3248 (0.5%)
Renal impairment	13/3257 (0.4%)		9/3248 (0.3%)
Renal mass	0/3257 (0%)		1/3248 (0%)
Urinary retention	1/3257 (0%)		0/3248 (0%)
Reproductive system and breast disorders
Acquired phimosis	0/3257 (0%)		1/3248 (0%)
Benign prostatic hyperplasia	0/3257 (0%)		1/3248 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	5/3257 (0.2%)		5/3248 (0.2%)
Acute respiratory distress syndrome	1/3257 (0%)		1/3248 (0%)
Acute respiratory failure	3/3257 (0.1%)		3/3248 (0.1%)
Bronchitis chronic	0/3257 (0%)		1/3248 (0%)
Bronchospasm	1/3257 (0%)		1/3248 (0%)
Chronic obstructive pulmonary disease	5/3257 (0.2%)		7/3248 (0.2%)
Dyspnoea	6/3257 (0.2%)		5/3248 (0.2%)
Dyspnoea exertional	0/3257 (0%)		1/3248 (0%)
Epistaxis	0/3257 (0%)		1/3248 (0%)
Haemothorax	1/3257 (0%)		0/3248 (0%)
Hypercapnia	0/3257 (0%)		1/3248 (0%)
Hypoxia	1/3257 (0%)		2/3248 (0.1%)
Interstitial lung disease	1/3257 (0%)		1/3248 (0%)
Lung infiltration	0/3257 (0%)		1/3248 (0%)
Pleural effusion	5/3257 (0.2%)		2/3248 (0.1%)
Pneumothorax	0/3257 (0%)		2/3248 (0.1%)
Pulmonary cavitation	0/3257 (0%)		1/3248 (0%)
Pulmonary embolism	5/3257 (0.2%)		7/3248 (0.2%)
Pulmonary fibrosis	1/3257 (0%)		1/3248 (0%)
Pulmonary hypertension	1/3257 (0%)		1/3248 (0%)
Pulmonary mass	0/3257 (0%)		1/3248 (0%)
Pulmonary oedema	3/3257 (0.1%)		2/3248 (0.1%)
Respiratory acidosis	0/3257 (0%)		1/3248 (0%)
Respiratory arrest	0/3257 (0%)		1/3248 (0%)
Respiratory depression	0/3257 (0%)		1/3248 (0%)
Respiratory distress	1/3257 (0%)		0/3248 (0%)
Respiratory failure	7/3257 (0.2%)		10/3248 (0.3%)
Skin and subcutaneous tissue disorders
Diabetic foot	0/3257 (0%)		1/3248 (0%)
Drug eruption	1/3257 (0%)		0/3248 (0%)
Panniculitis	1/3257 (0%)		0/3248 (0%)
Rash maculo-papular	0/3257 (0%)		1/3248 (0%)
Skin ulcer	0/3257 (0%)		2/3248 (0.1%)
Surgical and medical procedures
Cardioversion	1/3257 (0%)		0/3248 (0%)
Coronary artery bypass	1/3257 (0%)		0/3248 (0%)
Toe amputation	0/3257 (0%)		1/3248 (0%)
Vascular disorders
Aortic aneurysm	0/3257 (0%)		1/3248 (0%)
Aortic aneurysm rupture	1/3257 (0%)		0/3248 (0%)
Aortic dissection	1/3257 (0%)		0/3248 (0%)
Arterial stenosis	0/3257 (0%)		1/3248 (0%)
Arteriosclerosis	0/3257 (0%)		2/3248 (0.1%)
Arteriovenous fistula	0/3257 (0%)		1/3248 (0%)
Deep vein thrombosis	0/3257 (0%)		1/3248 (0%)
Hypertension	1/3257 (0%)		3/3248 (0.1%)
Hypertensive crisis	3/3257 (0.1%)		1/3248 (0%)
Hypotension	14/3257 (0.4%)		9/3248 (0.3%)
Hypovolaemic shock	0/3257 (0%)		1/3248 (0%)
Iliac artery embolism	1/3257 (0%)		0/3248 (0%)
Orthostatic hypotension	0/3257 (0%)		1/3248 (0%)
Peripheral embolism	1/3257 (0%)		0/3248 (0%)
Peripheral vascular disorder	0/3257 (0%)		1/3248 (0%)
Phlebitis	0/3257 (0%)		1/3248 (0%)
Shock	1/3257 (0%)		0/3248 (0%)
Subclavian steal syndrome	1/3257 (0%)		0/3248 (0%)
Thrombophlebitis	0/3257 (0%)		1/3248 (0%)
Other (Not Including Serious) Adverse Events
	Serelaxin (RLX030)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1336/3257 (41%)		1277/3248 (39.3%)
Blood and lymphatic system disorders
Anaemia	48/3257 (1.5%)		47/3248 (1.4%)
Cardiac disorders
Angina pectoris	17/3257 (0.5%)		15/3248 (0.5%)
Aortic valve incompetence	21/3257 (0.6%)		25/3248 (0.8%)
Aortic valve stenosis	23/3257 (0.7%)		13/3248 (0.4%)
Atrial fibrillation	46/3257 (1.4%)		45/3248 (1.4%)
Bradycardia	23/3257 (0.7%)		22/3248 (0.7%)
Cardiac failure	162/3257 (5%)		185/3248 (5.7%)
Mitral valve incompetence	52/3257 (1.6%)		47/3248 (1.4%)
Tricuspid valve incompetence	30/3257 (0.9%)		21/3248 (0.6%)
Ventricular tachycardia	37/3257 (1.1%)		24/3248 (0.7%)
Gastrointestinal disorders
Abdominal pain	18/3257 (0.6%)		19/3248 (0.6%)
Constipation	70/3257 (2.1%)		57/3248 (1.8%)
Diarrhoea	44/3257 (1.4%)		52/3248 (1.6%)
Nausea	59/3257 (1.8%)		51/3248 (1.6%)
Vomiting	30/3257 (0.9%)		24/3248 (0.7%)
General disorders
Non-cardiac chest pain	12/3257 (0.4%)		20/3248 (0.6%)
Pyrexia	31/3257 (1%)		41/3248 (1.3%)
Infections and infestations
Bronchitis	30/3257 (0.9%)		47/3248 (1.4%)
Cystitis	18/3257 (0.6%)		7/3248 (0.2%)
Pneumonia	17/3257 (0.5%)		22/3248 (0.7%)
Urinary tract infection	58/3257 (1.8%)		68/3248 (2.1%)
Investigations
Blood creatinine increased	36/3257 (1.1%)		49/3248 (1.5%)
Blood potassium decreased	15/3257 (0.5%)		20/3248 (0.6%)
Blood pressure decreased	36/3257 (1.1%)		23/3248 (0.7%)
Blood pressure systolic decreased	29/3257 (0.9%)		24/3248 (0.7%)
Blood urea increased	24/3257 (0.7%)		25/3248 (0.8%)
Metabolism and nutrition disorders
Gout	16/3257 (0.5%)		28/3248 (0.9%)
Hyperglycaemia	25/3257 (0.8%)		17/3248 (0.5%)
Hyperkalaemia	40/3257 (1.2%)		36/3248 (1.1%)
Hyperuricaemia	25/3257 (0.8%)		21/3248 (0.6%)
Hypoglycaemia	29/3257 (0.9%)		22/3248 (0.7%)
Hypokalaemia	263/3257 (8.1%)		241/3248 (7.4%)
Hyponatraemia	19/3257 (0.6%)		13/3248 (0.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	25/3257 (0.8%)		21/3248 (0.6%)
Back pain	22/3257 (0.7%)		26/3248 (0.8%)
Muscle spasms	79/3257 (2.4%)		49/3248 (1.5%)
Pain in extremity	27/3257 (0.8%)		32/3248 (1%)
Nervous system disorders
Dizziness	27/3257 (0.8%)		17/3248 (0.5%)
Headache	74/3257 (2.3%)		92/3248 (2.8%)
Psychiatric disorders
Anxiety	16/3257 (0.5%)		30/3248 (0.9%)
Confusional state	25/3257 (0.8%)		28/3248 (0.9%)
Insomnia	42/3257 (1.3%)		48/3248 (1.5%)
Renal and urinary disorders
Acute kidney injury	35/3257 (1.1%)		34/3248 (1%)
Haematuria	20/3257 (0.6%)		20/3248 (0.6%)
Renal failure	42/3257 (1.3%)		46/3248 (1.4%)
Renal impairment	48/3257 (1.5%)		55/3248 (1.7%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	6/3257 (0.2%)		17/3248 (0.5%)
Cough	41/3257 (1.3%)		36/3248 (1.1%)
Dyspnoea	17/3257 (0.5%)		15/3248 (0.5%)
Epistaxis	19/3257 (0.6%)		14/3248 (0.4%)
Vascular disorders
Hypertension	23/3257 (0.7%)		37/3248 (1.1%)
Hypotension	69/3257 (2.1%)		58/3248 (1.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Results Point of Contact

Name/Title	Study Director
Organization	Novartis Pharmaceuticals
Phone	862-778-8300
Email	novartis.email@novartis.com

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01870778

Other Study ID Numbers:

CRLX030A2301
2013-001498-25

First Posted:

Jun 6, 2013

Last Update Posted:

Mar 30, 2018

Last Verified:

Mar 1, 2018

RELAX-AHF-2: Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Key Inclusion Criteria:

Key Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

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Results Point of Contact