Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)
Study Details
Study Description
Brief Summary
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 2 |
Detailed Description
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Omecamtiv mecarbil
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Drug: Omecamtiv mecarbil
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Other Names:
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Placebo Comparator: Placebo
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Drug: Placebo
48-hour infusion of placebo
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Outcome Measures
Primary Outcome Measures
- The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. [48 hours]
Secondary Outcome Measures
- To characterize pharmacokinetics of omecamtiv mecarbil including metabolites following IV infusion and to evaluate the relationship between omecamtiv mecarbil plasma concentration and echocardiographic parameters in subjects with AHF [48 hours]
- To assess the safety and tolerability of 3 dose levels of IV omecamtiv mecarbil compared with placebo in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure [48 hours]
- To evaluate the effects of 48 hours treatment with IV omecamtiv mecarbil on additional measures of dyspnea, patient global assessment (PGA), change in NT-proBNP, incidence of worsening heart failure, and short term clinical outcomes [48 hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female 18 - 85 years
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Hospitalized for worsening heart failure, within 24 hours of initiating IV loop diuretic
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Dyspnea due to heart failure, at rest or with minimal exertion
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History of left ventricular ejection fraction (LVEF) ≤ 40%
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Elevated brain natriuretic peptide (BNP) or N-terminal fragment BNP (NT-proBNP)
Exclusion Criteria:
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Receiving IV vasopressor (excluding low dopamine), inotropic or mechanical support
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Acute coronary syndrome (ACS)
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Within 30 days prior to enrollment: cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation, ACS, coronary revascularization, transient ischemic attack (TIA) or stroke, sustained ventricular arrhythmia, or major surgery
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Severe valvular stenosis, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
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Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Research Site | Mobile | Alabama | United States | 36608 |
2 | Research Site | Inglewood | California | United States | 90301 |
3 | Research Site | La Jolla | California | United States | 92037 |
4 | Research Site | San Francisco | California | United States | 94121 |
5 | Research Site | Danbury | Connecticut | United States | 06810 |
6 | Research Site | Newark | Delaware | United States | 19718 |
7 | Research Site | Atlantis | Florida | United States | 33462 |
8 | Research Site | Clearwater | Florida | United States | 33756 |
9 | Research Site | Fort Lauderdale | Florida | United States | 33308 |
10 | Research Site | Miami | Florida | United States | 33133 |
11 | Research Site | Orlando | Florida | United States | 32803 |
12 | Research Site | Atlanta | Georgia | United States | 30322 |
13 | Research Site | Chicago | Illinois | United States | 60611 |
14 | Research Site | Peoria | Illinois | United States | 61636 |
15 | Research Site | Baltimore | Maryland | United States | 21201 |
16 | Research Site | Detroit | Michigan | United States | 48201 |
17 | Research Site | Detroit | Michigan | United States | 48202 |
18 | Research Site | Novi | Michigan | United States | 48374 |
19 | Research Site | Minneapolis | Minnesota | United States | 55417 |
20 | Research Site | Saint Louis | Missouri | United States | 63110 |
21 | Research Site | Lincoln | Nebraska | United States | 68506 |
22 | Research Site | Newark | New Jersey | United States | 07103 |
23 | Research Site | Bronx | New York | United States | 10467 |
24 | Research Site | Cortlandt Manor | New York | United States | 10567 |
25 | Research Site | Roslyn | New York | United States | 11576 |
26 | Research Site | Chapel Hill | North Carolina | United States | 27599 |
27 | Research Site | Charlotte | North Carolina | United States | 28204 |
28 | Research Site | Durham | North Carolina | United States | 27705 |
29 | Research Site | Winston-Salem | North Carolina | United States | 27103 |
30 | Research Site | Cincinnati | Ohio | United States | 45219 |
31 | Research Site | Cincinnati | Ohio | United States | 45220 |
32 | Research Site | Cincinnati | Ohio | United States | 45267 |
33 | Research Site | Cleveland | Ohio | United States | 44109 |
34 | Research Site | Columbus | Ohio | United States | 43210 |
35 | Research Site | Fairfield | Ohio | United States | 45014 |
36 | Research Site | Oklahoma City | Oklahoma | United States | 73120 |
37 | Research Site | Portland | Oregon | United States | 97239 |
38 | Research Site | Charleston | South Carolina | United States | 29425 |
39 | Research Site | Greenville | South Carolina | United States | 29605 |
40 | Research Site | Memphis | Tennessee | United States | 38120 |
41 | Research Site | Nashville | Tennessee | United States | 37203 |
42 | Research Site | Nashville | Tennessee | United States | 37232-8802 |
43 | Research Site | Tullahoma | Tennessee | United States | 37388 |
44 | Research Site | Houston | Texas | United States | 77030 |
45 | Research Site | Murray | Utah | United States | 84107 |
46 | Research Site | Darlinghurst | New South Wales | Australia | 2010 |
47 | Research Site | Woolloongabba | Queensland | Australia | 4102 |
48 | Research Site | Bedford Park | South Australia | Australia | 5042 |
49 | Research Site | Prahran | Victoria | Australia | 3181 |
50 | Research Site | Richmond | Victoria | Australia | 3121 |
51 | Research Site | Aalst | Belgium | 9300 | |
52 | Research Site | Bonheiden | Belgium | 2820 | |
53 | Research Site | Gent | Belgium | 9000 | |
54 | Research Site | Roeselare | Belgium | 8800 | |
55 | Research Site | Blagoevgrad | Bulgaria | 2700 | |
56 | Research Site | Kazanlak | Bulgaria | 6100 | |
57 | Research Site | Pazardzhik | Bulgaria | 4700 | |
58 | Research Site | Plovdiv | Bulgaria | 4002 | |
59 | Research Site | Sandanski | Bulgaria | 2800 | |
60 | Research Site | Smolyan | Bulgaria | 4400 | |
61 | Research Site | Sofia | Bulgaria | 1309 | |
62 | Research Site | Sofia | Bulgaria | 1431 | |
63 | Research Site | Sofia | Bulgaria | 1527 | |
64 | Research Site | Calgary | Alberta | Canada | T2N 4Z6 |
65 | Research Site | Edmonton | Alberta | Canada | T6G 2B7 |
66 | Research Site | Edmonton | Alberta | Canada | T6L 5X8 |
67 | Research Site | Halifax | Nova Scotia | Canada | B3H 3A7 |
68 | Research Site | Ottawa | Ontario | Canada | K1Y 4W7 |
69 | Research Site | Toronto | Ontario | Canada | M5B 1W8 |
70 | Research Site | Toronto | Ontario | Canada | M5G 1X5 |
71 | Research Site | Montreal | Quebec | Canada | H3G 1A4 |
72 | Research Site | Québec | Quebec | Canada | G1V 4G5 |
73 | Research Site | Sherbrooke | Quebec | Canada | J1H 5N4 |
74 | Research Site | Brno | Czechia | 625 00 | |
75 | Research Site | Brno | Czechia | 656 91 | |
76 | Research Site | Praha 2 | Czechia | 128 08 | |
77 | Research Site | Praha 5 | Czechia | 150 06 | |
78 | Research Site | Usti nad Labem | Czechia | 401 13 | |
79 | Research Site | Helsinki | Finland | 00029 | |
80 | Research Site | Turku | Finland | 20521 | |
81 | Research Site | Caen Cedex 9 | France | 14033 | |
82 | Research Site | Lille Cedex | France | 59037 | |
83 | Research Site | Montpellier cedex 05 | France | 34295 | |
84 | Research Site | Paris Cedex 13 | France | 75651 | |
85 | Research Site | Paris | France | 75010 | |
86 | Research Site | Strasbourg | France | 67091 | |
87 | Research Site | Toulouse Cedex 09 | France | 31403 | |
88 | Research Site | Bad Nauheim | Germany | 61231 | |
89 | Research Site | Dortmund | Germany | 44137 | |
90 | Research Site | Dresden | Germany | 01307 | |
91 | Research Site | Frankfurt | Germany | 60488 | |
92 | Research Site | Frankfurt | Germany | 60590 | |
93 | Research Site | Greifswald | Germany | 17475 | |
94 | Research Site | Halle/Saale | Germany | 06097 | |
95 | Research Site | Hamburg | Germany | 20246 | |
96 | Research Site | Homburg | Germany | 66421 | |
97 | Research Site | Langen | Germany | 63225 | |
98 | Research Site | Regensburg | Germany | 93053 | |
99 | Research Site | Stuttgart | Germany | 70376 | |
100 | Research Site | Würzburg | Germany | 97080 | |
101 | Research Site | Athens | Greece | 11528 | |
102 | Research Site | Athens | Greece | 16673 | |
103 | Research Site | Haidari | Greece | 12462 | |
104 | Research Site | Heraklion | Greece | 71110 | |
105 | Research Site | Patra | Greece | 26500 | |
106 | Research Site | Budapest | Hungary | 1023 | |
107 | Research Site | Budapest | Hungary | 1122 | |
108 | Research Site | Budapest | Hungary | 1125 | |
109 | Research Site | Budapest | Hungary | 1134 | |
110 | Research Site | Pecs | Hungary | 7624 | |
111 | Research Site | Szolnok | Hungary | 5004 | |
112 | Research Site | Brescia | Italy | 25125 | |
113 | Research Site | Cagliari | Italy | 09134 | |
114 | Research Site | Pavia | Italy | 27100 | |
115 | Research Site | Udine | Italy | 33100 | |
116 | Research Site | Kaunas | Lithuania | 50009 | |
117 | Research Site | Vilnius | Lithuania | 08661 | |
118 | Research Site | Delft | Netherlands | 2625 AD | |
119 | Research Site | Deventer | Netherlands | 7416 SE | |
120 | Research Site | Utrecht | Netherlands | 3584 CX | |
121 | Research Site | Oslo | Norway | 0424 | |
122 | Research Site | Stavanger | Norway | 4011 | |
123 | Research Site | Bialystok | Poland | 15-276 | |
124 | Research Site | Gdansk | Poland | 80-952 | |
125 | Research Site | Krakow | Poland | 31-202 | |
126 | Research Site | Krakow | Poland | 31-501 | |
127 | Research Site | Lodz | Poland | 91-347 | |
128 | Research Site | Lublin | Poland | 20-954 | |
129 | Research Site | Wroclaw | Poland | 50-981 | |
130 | Research Site | Moscow | Russian Federation | 109240 | |
131 | Research Site | Moscow | Russian Federation | 111539 | |
132 | Research Site | Moscow | Russian Federation | 115093 | |
133 | Research Site | Moscow | Russian Federation | 117292 | |
134 | Research Site | Moscow | Russian Federation | 119620 | |
135 | Research Site | Moscow | Russian Federation | 119991 | |
136 | Research Site | Moscow | Russian Federation | 127299 | |
137 | Research Site | Moscow | Russian Federation | 127473 | |
138 | Research Site | Saint Petersburg | Russian Federation | 197341 | |
139 | Research Site | Saint-Petersburg | Russian Federation | 195067 | |
140 | Research Site | St Petersburg | Russian Federation | 198205 | |
141 | Research Site | St. Petersburg | Russian Federation | 199106 | |
142 | Research Site | St.-Petrsburg | Russian Federation | 196247 | |
143 | Research Site | Bratislava | Slovakia | 826 06 | |
144 | Research Site | Bratislava | Slovakia | 851 07 | |
145 | Research Site | Kosice | Slovakia | 040 66 | |
146 | Research Site | Nitra | Slovakia | 949 01 | |
147 | Research Site | Bristol | United Kingdom | BS2 8HW | |
148 | Research Site | Cottingham | United Kingdom | HU16 5JQ | |
149 | Research Site | Glasgow | United Kingdom | G11 6NT | |
150 | Research Site | Harrow | United Kingdom | HA1 3UJ |
Sponsors and Collaborators
- Cytokinetics
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20100754