This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.
Study Details
Study Description
Brief Summary
The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic heart failure (CHF) with preserved ejection fraction (LVEF > 40%).
Secondary objectives are to assess Patient-Reported Outcome (PRO)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Empagliflozin
|
Drug: Empagliflozin
Film-coated tablet
Other Names:
|
Active Comparator: Placebo
|
Drug: Placebo
Film-coated tablet
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to Week 12 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes in Standardised Conditions (6MWTD) [At baseline and at Week 12]
Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions (6MWTD). If repeated 6-minutes walk test (6MWT) measurements were available for the same day, the longest distance was used for analysis. Change from baseline was defined as the distance walked in 6 minutes at Week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 12 but did not perform the 6MWT, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above.
Secondary Outcome Measures
- Change From Baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS) [At baseline and at Week 12]
Change from baseline in KCCQ-TSS was defined as the endpoint value at week 12 minus the last available measurement before start of treatment with randomised study medication. The KCCQ is 23 item self-administered questionnaire and comprises 7 domains: physical limitation, symptom frequency, symptom burden, symptom stability, social limitation, self-efficacy and quality of life. Additionally 3 summary scores exist: TSS, clinical summary score, and overall summary score. The scores of the KCCQ domains and summary scores range from 0 to 100, with higher score indicating better outcome. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.
- Change From Baseline to Week 12 in Chronic Heart Failure Questionnaire Self- Administered Standardized Format (CHQ-SAS) Dyspnea Score [At baseline and at Week 12]
Change from baseline in CHQ-SAS was defined as the endpoint value at week 12 minus the last available endpoint value before start of treatment with randomised study medication. The CHQ-SAS evaluates 3 domains: dyspnoea, fatigue, and emotional function. Scores of the domains range from 1 to 7, with higher score indicating better quality of life. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.
- Change From Baseline to Week 6 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes [At baseline and at Week 6]
Change from baseline to week 6 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at Week 6 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 6 but did not perform the 6-Minuted Walking Test, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 6, an imputed value was used.
- Change From Baseline in Clinical Congestion Score at Week 12 [At baseline and at Week 12]
Change from baseline to week 12 in Clinical Congestion score is defined as the score-value at week 12 minus the score-value at baseline. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. The Clinical Congestion Score (summary score) is based on 3 items: orthopnoea, jugular venous distention (JVD) and oedema. Each item was assessed through a 4-measure questionnaire, which was further converted to a standardised 4-point scale ranging from 0 to 3, with 0 indicating no or fewer symptoms and 3 indicating continous or more symptoms. If at least 2 of the 3 items are not missing, the summary score is calculated as: (average over items JVD, orthopnea and oedema actually answered)*3. The summary score ranges from 0 to 9, with lower value indicating better health, and higher value indicating worse health. Mean is adjusted mean.
- Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12 [At baseline and at Week 12]
Change from baseline to week 12 in PGI-S of Heart Failure Symptoms. The Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the Patient to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.
- Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12 [At baseline and at Week 12]
Change from baseline to week 12 in Patient Global Impression of Severity (PGI-S) of dyspnoea. The PGI-S of Dyspnoea is a 1-item questionnaire designed to assess the participant´s impression of symptom severity, specifically dyspnoea. The PGI-S item asks the participant to choose one response that best describes how his/her dyspnoea is now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.
- Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12 [Week 12]
The Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of change in heart failure symptoms, specifically: shortness of breath, fatigue, and swelling. The PGI-C asks the patient to choose one Response that best describes the overall change (if any) in his/her heart failure symptoms, specifically: shortness of breath, fatigue, and swelling since he/she started taking the study medication on a 7- category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).
- Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12 [Week 12]
The PGI-C in Dyspnoea is a 1-item questionnaire designed to assess the patient's Impression of change in dyspnoea. The PGI-C asks the patient to choose one response that best describes the change (if any) in his/her shortness of breath when performing usual activities since he/she started taking the study medication on a 7-category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).
- Relative Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NTproBNP) at Week 12 [Within 3 weeks prior to treatment start and at Week 12.]
Relative change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NTproBNP). Relative change from baseline is expressed as ratio of week 12 to baseline. Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. Mean is adjusted mean.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Of full age of consent (according to local legislation, usually ≥ 18 years) at screening.
-
Male or female patients. Women of child bearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
-
Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial
-
Six minute walk test (6MWT) distance ≤350 m at screening and at baseline.
-
Patients with CHF diagnosed for at least 3 months before Visit 1, and currently in NYHA class II-IV
-
Chronic heart failure (CHF) with preserved Ejection fraction (EF) defined as left ventricle ejection fraction(LVEF) > 40 % as per echocardiography at Visit 1 per local reading and no prior measurement of LVEF ≤ 40% under stable conditions.
-
Elevated N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/ml for patients without atrial fibrillation (AF), OR > 600 pg/ml for patients with AF, as analysed at the Central laboratory at Visit 1
-
Patients must have at least one of the following evidence of heart failure (HF):
-
Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1, OR
-
Documented Hospitalization for Heart Failure (HHF) within 12 months prior to Visit 1
-
Consistent with prevailing CV guidelines, if oral diuretics are prescribed to control symptoms, patients must be on an appropriate and stable dose of oral diuretics for at least 2 weeks prior to Visit 1 to control symptoms.
-
Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).
Exclusion Criteria:
-
Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or transient ischemic attack in past 90 days prior to Visit 1
-
Acute decompensated HF (exacerbation of CHF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
-
Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0168)
-
Type 1 Diabetes Mellitus (T1DM)
-
Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
-
Symptomatic hypotension or a systolic blood pressure (SBP) < 100 mmHg at Visit 1 or 2
-
SBP ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2
-
Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 1 (Screening)
-
Unstable angina pectoris in past 30 days prior to Visit 1
-
Largest distance walked in 6 minutes (6MWTD) at baseline <100m.
-
Any presence of condition that precludes exercise testing such as:
-
claudication,
-
uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
-
significant musculoskeletal disease,
-
primary pulmonary hypertension,
-
severe obesity (body mass index ≥40.0 kg/m2),
-
orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
-
amputation with artificial limb without stable prosthesis function for the past 3 months
-
Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWT
-
Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
-
ICD implantation within 1 month prior to Visit 1 or planned during the course of the trial
-
Implanted cardiac resynchronisation therapy (CRT)
-
Treatment with i.v. iron therapy or erythropoietin (EPO) within 3 months prior to screening.
-
Further exclusion criteria applies
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mobile Heart Specialists, PC | Mobile | Alabama | United States | 36608 |
2 | The Center for Clinical Trials, Inc. | Saraland | Alabama | United States | 36571 |
3 | California Heart Specialists | Huntington Beach | California | United States | 92648 |
4 | Manshadi Heart Institute, Inc | Stockton | California | United States | 95204 |
5 | University of California Los Angeles | Torrance | California | United States | 90502 |
6 | University of Colorado Denver | Aurora | Colorado | United States | 80045 |
7 | Western Connecticut Health Network | Danbury | Connecticut | United States | 06810 |
8 | Bio1 Clinical Research | Miami Beach | Florida | United States | 33140 |
9 | Infinite Clinical Research | Miami | Florida | United States | 33133 |
10 | Advance Medical Research Center | Miami | Florida | United States | 33135 |
11 | Pharmacology Research, LLC | North Miami Beach | Florida | United States | 33169 |
12 | Palm Beach Gardens Research Center, LLC | Palm Beach Gardens | Florida | United States | 33410 |
13 | East Coast Institute for Research, LLC | Saint Augustine | Florida | United States | 32086 |
14 | Cozy Research LLC | Zephyrhills | Florida | United States | 33541 |
15 | Grady Memorial Hospital | Atlanta | Georgia | United States | 30303 |
16 | Georgia Arrhythmia Consultants and Research Institute | Warner Robins | Georgia | United States | 31093 |
17 | St Luke's Clinic - Idaho Cardiology Associates | Boise | Idaho | United States | 83712 |
18 | Northwest Heart Clinical Research, LLC | Arlington Heights | Illinois | United States | 60005 |
19 | Clinical Investigation Specialists, Inc | Gurnee | Illinois | United States | 60031 |
20 | Chicago Medical Research | Hazel Crest | Illinois | United States | 60429 |
21 | Midwest Heart and Vascular Specialists | Overland Park | Kansas | United States | 66211 |
22 | Grace Research, LLC | Bossier City | Louisiana | United States | 71111 |
23 | Grace Research, LLC | Shreveport | Louisiana | United States | 71107 |
24 | Clinical Trials of America LA, LLC | West Monroe | Louisiana | United States | 71291 |
25 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
26 | John D. Dingell VA Medical Center | Detroit | Michigan | United States | 48201 |
27 | Med Research One | Florissant | Missouri | United States | 63031 |
28 | Cox Medical Center South | Springfield | Missouri | United States | 65807 |
29 | The DOCS | Las Vegas | Nevada | United States | 89113 |
30 | Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08901 |
31 | Albany Stratton VA Medical Center Albany, NY | Albany | New York | United States | 12208 |
32 | UNC REX Healthcare | Raleigh | North Carolina | United States | 27607 |
33 | PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | United States | 27804 |
34 | PMG Research of Wilmington, LLC | Wilmington | North Carolina | United States | 28401 |
35 | Rama Research LLC | Marion | Ohio | United States | 43302 |
36 | Columbia Heart Clinic | Columbia | South Carolina | United States | 29203 |
37 | Black Hills Cardiovascular Research | Rapid City | South Dakota | United States | 57701 |
38 | The Jackson Clinic, PA | Jackson | Tennessee | United States | 38301 |
39 | DiscoveResearch, Inc. | Beaumont | Texas | United States | 77701 |
40 | Angiocardiac Care of Texas | Houston | Texas | United States | 77025 |
41 | Acacia Medical Research Institute,LLC | Sugar Land | Texas | United States | 77478 |
42 | Mary Washington Hospital Research Department | Fredericksburg | Virginia | United States | 22401 |
43 | York Clinical Research, LLC | Norfolk | Virginia | United States | 23510 |
44 | Canberra Hospital | Garran | Australian Capital Territory | Australia | 2605 |
45 | University of the Sunshine Coast | Birtinya | Queensland | Australia | 4575 |
46 | Peninsular Health CV Research Unit | Frankston | Victoria | Australia | 3199 |
47 | University of Calgary | Calgary | Alberta | Canada | T2N 4Z6 |
48 | KMH Cardiology Centres Inc. | Mississauga | Ontario | Canada | L5K 2L3 |
49 | Toronto Heart Centre | Toronto | Ontario | Canada | M4P 1E4 |
50 | Sameh Fikry Medicine Professional Corporation | Waterloo | Ontario | Canada | N2J 1C4 |
51 | CIMS Studienzentrum Bamberg GmbH | Bamberg | Germany | 96049 | |
52 | Klinische Forschung Berlin GbR | Berlin | Germany | 10787 | |
53 | Charité - Universitätsmedizin Berlin | Berlin | Germany | 13353 | |
54 | Cardiologicum Dresden und Pirna | Dresden | Germany | 01277 | |
55 | Universitätsklinikum Düsseldorf | Düsseldorf | Germany | 40225 | |
56 | IKF Pneumologie GmbH & Co. KG | Frankfurt | Germany | 60596 | |
57 | Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH | Freiburg | Germany | 79106 | |
58 | Universitätsklinikum Köln (AöR) | Köln | Germany | 50937 | |
59 | Universitätsklinikum Leipzig | Leipzig | Germany | 04103 | |
60 | Universitätsklinikum Magdeburg AöR | Magdeburg | Germany | 39120 | |
61 | Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Germany | 55131 | |
62 | Universitätsklinikum Ulm | Ulm | Germany | 89081 | |
63 | Universitätsklinikum Würzburg | Würzburg | Germany | 97080 | |
64 | General Hospital of Athens Konstantopoulio-Agia Olga | Athens | Greece | 14233 | |
65 | General Hospital of Athens "G. Gennimatas" | Athens | Greece | 15669 | |
66 | General Hospital of Chalkida | Chalkida | Greece | 34100 | |
67 | University General Hospital of Heraklion | Herakleion, Crete | Greece | 71110 | |
68 | Univ. Gen. Hosp. of Ioannina | Ioannina | Greece | 45500 | |
69 | University Hospital of Thessaloniki AHEPA | Thessaloniki | Greece | 54636 | |
70 | Centro Cardiologico Monzino-IRCCS | Milano | Italy | 20138 | |
71 | Asst Santi Paolo E Carlo | Milano | Italy | 20142 | |
72 | ASST Grande Ospedale Metropolitano Niguarda | Milano | Italy | 20162 | |
73 | Ospedale Regina Montis Regalis | Mondovì (CN) | Italy | 12084 | |
74 | Università Federico II | Napoli | Italy | 80131 | |
75 | Università degli studi di Palermo | Palermo | Italy | 90133 | |
76 | IRCCS San Raffaele | Roma | Italy | 00163 | |
77 | Sykehuset Østfold Kalnes | Grålum | Norway | N-1714 | |
78 | Oslo Universitetssykehus HF, Rikshospitalet | Oslo | Norway | N-0372 | |
79 | Helse Stavanger, Stavanger Universitetssykehus | Stavanger | Norway | N-4011 | |
80 | St. Olavs Hospital, Universitetssykehuset i Trondheim | Trondheim | Norway | N-7030 | |
81 | INTERCORE Medical Center | Bydgoszcz | Poland | 85-605 | |
82 | 10.Military Clin.Hospital&Polyclinic | Bydgoszcz | Poland | 85681 | |
83 | Leszek Bryniarski Specialized Medical Cabinet | Krakow | Poland | 30-082 | |
84 | Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz | Lodz | Poland | 91-425 | |
85 | Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard | Lodz | Poland | 92-213 | |
86 | Provincial Specialist M. Kopernik Hospital | Lodz | Poland | 93-513 | |
87 | Independent Public Healthcare, Dept. of Cardiology, Pulawy | Pulawy | Poland | 24100 | |
88 | Central Hospital of Medical Academy, Warsaw | Warsaw | Poland | 02-097 | |
89 | 4. Military Clinical Hospital with Polyclinic SP ZOZ | Wroclaw | Poland | 50 981 | |
90 | CHLO, EPE - Hospital de Santa Cruz | Carnaxide | Portugal | 2795 | |
91 | CHUC - Centro Hospitalar e Universitário de Coimbra, EPE | Coimbra | Portugal | 3041-801 | |
92 | Centro Hosp. de Leiria-Pombal | Leiria | Portugal | 2410-197 | |
93 | CHLC, EPE - Hospital de Santa Marta | Lisboa | Portugal | 1169-024 | |
94 | CHLO, EPE - Hospital S. Francisco Xavier | Lisboa | Portugal | 1449-005 | |
95 | CHULN, EPE - Hospital de Santa Maria | Lisboa | Portugal | 1649-035 | |
96 | Centro Hospitalar Universitário São João,EPE | Porto | Portugal | 4200-319 | |
97 | Hospital General Universitario de Alicante | Alicante | Spain | 03010 | |
98 | Hospital Germans Trias i Pujol | Badalona | Spain | 08916 | |
99 | Hospital San Rafael | Granada | Spain | 18001 | |
100 | Hospital de la Inmaculada Concepción | Granada | Spain | 18004 | |
101 | Hospital Universitario Virgen de las Nieves | Granada | Spain | 18014 | |
102 | Hospital La Princesa | Madrid | Spain | 28006 | |
103 | Hospital Ramón y Cajal | Madrid | Spain | 28034 | |
104 | Hospital Clínico de Valencia | Valencia | Spain | 46010 | |
105 | Sahlgrenska US, Göteborg | Göteborg | Sweden | 413 45 | |
106 | Sahlgrenska Universitetssjukhuset, Östra | Göteborg | Sweden | 416 85 | |
107 | Skånes universitetssjukhus, Lund | Lund | Sweden | 221 85 | |
108 | Akardo Med Site | Stockholm | Sweden | 11446 |
Sponsors and Collaborators
- Boehringer Ingelheim
- Eli Lilly and Company
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 1245-0167
- 2017-004072-59
Study Results
Participant Flow
Recruitment Details | Randomised, double-blind, placebo-controlled, parallel-group trial in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF) to evaluate the effect of Empagliflozin versus Placebo on exercise and heart failure symptoms. |
---|---|
Pre-assignment Detail | Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Period Title: Overall Study | ||
STARTED | 158 | 157 |
COMPLETED | 147 | 144 |
NOT COMPLETED | 11 | 13 |
Baseline Characteristics
Arm/Group Title | Placebo | 10 mg Empagliflozin | Total |
---|---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). | Total of all reporting groups |
Overall Participants | 158 | 157 | 315 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
73.9
(8.6)
|
73.0
(9.0)
|
73.5
(8.8)
|
Sex: Female, Male (Count of Participants) | |||
Female |
66
41.8%
|
70
44.6%
|
136
43.2%
|
Male |
92
58.2%
|
87
55.4%
|
179
56.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
19
12%
|
18
11.5%
|
37
11.7%
|
Not Hispanic or Latino |
139
88%
|
138
87.9%
|
277
87.9%
|
Unknown or Not Reported |
0
0%
|
1
0.6%
|
1
0.3%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
2
1.3%
|
3
1.9%
|
5
1.6%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
19
12%
|
13
8.3%
|
32
10.2%
|
White |
135
85.4%
|
140
89.2%
|
275
87.3%
|
More than one race |
2
1.3%
|
0
0%
|
2
0.6%
|
Unknown or Not Reported |
0
0%
|
1
0.6%
|
1
0.3%
|
Exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance at baseline (Meter) [Median (Inter-Quartile Range) ] | |||
Median (Inter-Quartile Range) [Meter] |
299.5
|
297.0
|
299.0
|
Outcome Measures
Title | Change From Baseline to Week 12 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes in Standardised Conditions (6MWTD) |
---|---|
Description | Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions (6MWTD). If repeated 6-minutes walk test (6MWT) measurements were available for the same day, the longest distance was used for analysis. Change from baseline was defined as the distance walked in 6 minutes at Week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 12 but did not perform the 6MWT, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. |
Time Frame | At baseline and at Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomised Set: All participants that were randomised, regardless of whether treated or not. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 158 | 157 |
Median (Inter-Quartile Range) [Meter (m)] |
5.0
|
10.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | H0: There is no difference between the effect of Placebo and the effect of empagliflozin. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.3660 |
Comments | ||
Method | Wilcoxon rank test, normal approximation | |
Comments | ||
Method of Estimation | Estimation Parameter | Median difference (HL-estimate) |
Estimated Value | 4.0 | |
Confidence Interval |
(2-Sided) 95% -5.0 to 13.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated. |
Title | Change From Baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS) |
---|---|
Description | Change from baseline in KCCQ-TSS was defined as the endpoint value at week 12 minus the last available measurement before start of treatment with randomised study medication. The KCCQ is 23 item self-administered questionnaire and comprises 7 domains: physical limitation, symptom frequency, symptom burden, symptom stability, social limitation, self-efficacy and quality of life. Additionally 3 summary scores exist: TSS, clinical summary score, and overall summary score. The scores of the KCCQ domains and summary scores range from 0 to 100, with higher score indicating better outcome. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed. |
Time Frame | At baseline and at Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomised Set: All participants that were randomised, regardless of whether treated or not. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 158 | 157 |
Median (Inter-Quartile Range) [Score on a scale] |
2.08
|
4.17
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | H0: There is no difference between the effect of Placebo and the effect of empagliflozin. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.2783 |
Comments | ||
Method | Wilcoxon rank test, normal approximation | |
Comments | ||
Method of Estimation | Estimation Parameter | Median difference (HL-estimate) |
Estimated Value | 2.08 | |
Confidence Interval |
(2-Sided) 95% -2.08 to 6.25 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann estimate for the median difference was calculated. |
Title | Change From Baseline to Week 12 in Chronic Heart Failure Questionnaire Self- Administered Standardized Format (CHQ-SAS) Dyspnea Score |
---|---|
Description | Change from baseline in CHQ-SAS was defined as the endpoint value at week 12 minus the last available endpoint value before start of treatment with randomised study medication. The CHQ-SAS evaluates 3 domains: dyspnoea, fatigue, and emotional function. Scores of the domains range from 1 to 7, with higher score indicating better quality of life. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed. |
Time Frame | At baseline and at Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the randomised set (RS) who have no missing values at baseline. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 158 | 156 |
Median (Inter-Quartile Range) [Score on a scale] |
0.20
|
0.10
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | H0: There is no difference between the effect of Placebo and the effect of empagliflozin. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.5512 |
Comments | ||
Method | Wilcoxon rank test, normal approximation | |
Comments | ||
Method of Estimation | Estimation Parameter | Median difference (HL-estimate) |
Estimated Value | -0.07 | |
Confidence Interval |
(2-Sided) 95% -0.35 to 0.20 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated. |
Title | Change From Baseline to Week 6 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes |
---|---|
Description | Change from baseline to week 6 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at Week 6 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 6 but did not perform the 6-Minuted Walking Test, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 6, an imputed value was used. |
Time Frame | At baseline and at Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
Randomised Set: All participants that were randomised, regardless of whether treated or not. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 158 | 157 |
Median (Inter-Quartile Range) [Meter (m)] |
1.0
|
7.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | H0: There is no difference between the effect of Placebo and the effect of empagliflozin. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.3657 |
Comments | ||
Method | Wilcoxon rank test, normal approximation | |
Comments | ||
Method of Estimation | Estimation Parameter | Median Difference (HL-estimate) |
Estimated Value | 3.0 | |
Confidence Interval |
(2-Sided) 95% -4.0 to 11.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated. |
Title | Change From Baseline in Clinical Congestion Score at Week 12 |
---|---|
Description | Change from baseline to week 12 in Clinical Congestion score is defined as the score-value at week 12 minus the score-value at baseline. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. The Clinical Congestion Score (summary score) is based on 3 items: orthopnoea, jugular venous distention (JVD) and oedema. Each item was assessed through a 4-measure questionnaire, which was further converted to a standardised 4-point scale ranging from 0 to 3, with 0 indicating no or fewer symptoms and 3 indicating continous or more symptoms. If at least 2 of the 3 items are not missing, the summary score is calculated as: (average over items JVD, orthopnea and oedema actually answered)*3. The summary score ranges from 0 to 9, with lower value indicating better health, and higher value indicating worse health. Mean is adjusted mean. |
Time Frame | At baseline and at Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Only participants in the randomised set (RS) who have values at baseline and at week 12. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 155 | 156 |
Mean (Standard Deviation) [Score on scale] |
-0.28
(0.08)
|
-0.36
(0.08)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.4440 |
Comments | ||
Method | Mixed Model Repeated Measure (MMRM) | |
Comments | Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors. | |
Method of Estimation | Estimation Parameter | Difference of adjusted mean |
Estimated Value | -0.09 | |
Confidence Interval |
(2-Sided) 95% -0.31 to 0.14 |
|
Parameter Dispersion |
Type: Standard Deviation Value: 0.11 |
|
Estimation Comments |
Title | Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12 |
---|---|
Description | Change from baseline to week 12 in PGI-S of Heart Failure Symptoms. The Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the Patient to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12. |
Time Frame | At baseline and at Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Only participants in the randomised set (RS) who have values at baseline and at week 12. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 154 | 153 |
4 categories improvement |
1
0.6%
|
0
0%
|
3 categories improvement |
2
1.3%
|
1
0.6%
|
2 categories improvement |
11
7%
|
8
5.1%
|
1 category improvement |
46
29.1%
|
42
26.8%
|
No change |
70
44.3%
|
79
50.3%
|
1 category deterioration |
17
10.8%
|
16
10.2%
|
2 categories deterioration |
6
3.8%
|
6
3.8%
|
3 categories deterioration |
0
0%
|
1
0.6%
|
4 categories deterioration |
1
0.6%
|
0
0%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.3924 |
Comments | ||
Method | Cochran-Mantel-Haenszel test | |
Comments | Test on difference in mean treatment scores, based on modified ridit scores. |
Title | Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12 |
---|---|
Description | Change from baseline to week 12 in Patient Global Impression of Severity (PGI-S) of dyspnoea. The PGI-S of Dyspnoea is a 1-item questionnaire designed to assess the participant´s impression of symptom severity, specifically dyspnoea. The PGI-S item asks the participant to choose one response that best describes how his/her dyspnoea is now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12. |
Time Frame | At baseline and at Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Only participants in the randomised set (RS) who have values at baseline and at week 12. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 154 | 153 |
4 categories improvement |
1
0.6%
|
0
0%
|
3 categories improvement |
4
2.5%
|
1
0.6%
|
2 categories improvement |
8
5.1%
|
13
8.3%
|
1 category improvement |
45
28.5%
|
48
30.6%
|
No change |
70
44.3%
|
70
44.6%
|
1 category deterioration |
18
11.4%
|
20
12.7%
|
2 categories deterioration |
7
4.4%
|
1
0.6%
|
3 categories deterioration |
1
0.6%
|
0
0%
|
4 categories deterioration |
0
0%
|
0
0%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.4435 |
Comments | ||
Method | Cochran-Mantel-Haenszel test | |
Comments | Test on difference in mean treatment scores, based on modified ridit scores. |
Title | Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12 |
---|---|
Description | The Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of change in heart failure symptoms, specifically: shortness of breath, fatigue, and swelling. The PGI-C asks the patient to choose one Response that best describes the overall change (if any) in his/her heart failure symptoms, specifically: shortness of breath, fatigue, and swelling since he/she started taking the study medication on a 7- category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3). |
Time Frame | Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Only participants in the randomised set (RS) who have values at week 12. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 154 | 153 |
Very much worse |
1
0.6%
|
0
0%
|
Much worse |
0
0%
|
3
1.9%
|
A little worse |
11
7%
|
7
4.5%
|
No change |
62
39.2%
|
55
35%
|
A little better |
41
25.9%
|
48
30.6%
|
Much better |
31
19.6%
|
35
22.3%
|
Very much better |
8
5.1%
|
5
3.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.5124 |
Comments | ||
Method | Cochran-Mantel-Haenszel test | |
Comments | Test on difference in mean treatment scores, based on modified ridit scores. |
Title | Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12 |
---|---|
Description | The PGI-C in Dyspnoea is a 1-item questionnaire designed to assess the patient's Impression of change in dyspnoea. The PGI-C asks the patient to choose one response that best describes the change (if any) in his/her shortness of breath when performing usual activities since he/she started taking the study medication on a 7-category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3). |
Time Frame | Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Only participants in the randomised set (RS) who have values at week 12. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 154 | 153 |
Very much worse |
0
0%
|
0
0%
|
Much worse |
2
1.3%
|
3
1.9%
|
A little worse |
6
3.8%
|
7
4.5%
|
No change |
72
45.6%
|
57
36.3%
|
A little better |
32
20.3%
|
45
28.7%
|
Much better |
31
19.6%
|
36
22.9%
|
Very much better |
11
7%
|
5
3.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.5713 |
Comments | ||
Method | Cochran-Mantel-Haenszel test | |
Comments | Test on difference in mean treatment scores, based on modified ridit scores. |
Title | Relative Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NTproBNP) at Week 12 |
---|---|
Description | Relative change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NTproBNP). Relative change from baseline is expressed as ratio of week 12 to baseline. Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. Mean is adjusted mean. |
Time Frame | Within 3 weeks prior to treatment start and at Week 12. |
Outcome Measure Data
Analysis Population Description |
---|
Only participants in the randomised set (RS) who had values at baseline and at week 12. |
Arm/Group Title | Placebo | 10 mg Empagliflozin |
---|---|---|
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). |
Measure Participants | 155 | 156 |
Mean (95% Confidence Interval) [Ratio] |
1.04
|
0.99
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 10 mg Empagliflozin |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.4032 |
Comments | ||
Method | Mixed model repeated Measure (MMRM) | |
Comments | Covariates: Visit-by-treatment interaction and baseline-by-visit interaction. Unstructured covariance structure to model within-patient errors. | |
Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio |
Estimated Value | 0.95 | |
Confidence Interval |
(2-Sided) 95% 0.85 to 1.07 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Adjusted geometric mean ratio [Empagliflozin/Placebo] of relative change to baseline. |
Adverse Events
Time Frame | From first intake of study medication, until 7 days after last intake of study medication, up to 92 days. | |||
---|---|---|---|---|
Adverse Event Reporting Description | Treated Set: All participants who were treated with at least one dose of study medication. | |||
Arm/Group Title | Placebo | 10 mg Empagliflozin | ||
Arm/Group Description | 1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF > 40%). | 1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%). | ||
All Cause Mortality |
||||
Placebo | 10 mg Empagliflozin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/158 (0%) | 1/157 (0.6%) | ||
Serious Adverse Events |
||||
Placebo | 10 mg Empagliflozin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 29/158 (18.4%) | 20/157 (12.7%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/158 (0.6%) | 0/157 (0%) | ||
Cardiac disorders | ||||
Angina unstable | 0/158 (0%) | 1/157 (0.6%) | ||
Atrial fibrillation | 2/158 (1.3%) | 2/157 (1.3%) | ||
Atrial flutter | 0/158 (0%) | 1/157 (0.6%) | ||
Cardiac arrest | 0/158 (0%) | 1/157 (0.6%) | ||
Cardiac failure | 13/158 (8.2%) | 6/157 (3.8%) | ||
Pericarditis | 1/158 (0.6%) | 0/157 (0%) | ||
Endocrine disorders | ||||
Hypothyroidism | 0/158 (0%) | 1/157 (0.6%) | ||
Gastrointestinal disorders | ||||
Abdominal hernia | 1/158 (0.6%) | 0/157 (0%) | ||
Abdominal pain | 1/158 (0.6%) | 0/157 (0%) | ||
Diarrhoea | 1/158 (0.6%) | 0/157 (0%) | ||
Dysphagia | 0/158 (0%) | 1/157 (0.6%) | ||
General disorders | ||||
Chest pain | 0/158 (0%) | 1/157 (0.6%) | ||
Generalised oedema | 0/158 (0%) | 1/157 (0.6%) | ||
Hepatobiliary disorders | ||||
Cholecystitis | 1/158 (0.6%) | 0/157 (0%) | ||
Cholecystitis acute | 1/158 (0.6%) | 0/157 (0%) | ||
Drug-induced liver injury | 0/158 (0%) | 1/157 (0.6%) | ||
Hepatic haemorrhage | 1/158 (0.6%) | 0/157 (0%) | ||
Hepatic mass | 1/158 (0.6%) | 0/157 (0%) | ||
Infections and infestations | ||||
Arthritis bacterial | 1/158 (0.6%) | 0/157 (0%) | ||
Asymptomatic bacteriuria | 0/158 (0%) | 1/157 (0.6%) | ||
Cellulitis | 1/158 (0.6%) | 0/157 (0%) | ||
Diverticulitis | 0/158 (0%) | 1/157 (0.6%) | ||
Helicobacter duodenitis | 0/158 (0%) | 1/157 (0.6%) | ||
Helicobacter gastritis | 0/158 (0%) | 1/157 (0.6%) | ||
Necrotising fasciitis | 1/158 (0.6%) | 0/157 (0%) | ||
Respiratory tract infection | 1/158 (0.6%) | 0/157 (0%) | ||
Urinary tract infection | 1/158 (0.6%) | 0/157 (0%) | ||
Urosepsis | 0/158 (0%) | 1/157 (0.6%) | ||
Injury, poisoning and procedural complications | ||||
Accidental overdose | 1/158 (0.6%) | 0/157 (0%) | ||
Investigations | ||||
Blood glucose increased | 0/158 (0%) | 1/157 (0.6%) | ||
Metabolism and nutrition disorders | ||||
Hyperglycaemia | 0/158 (0%) | 1/157 (0.6%) | ||
Metabolic alkalosis | 0/158 (0%) | 1/157 (0.6%) | ||
Musculoskeletal and connective tissue disorders | ||||
Back pain | 0/158 (0%) | 1/157 (0.6%) | ||
Haemarthrosis | 0/158 (0%) | 1/157 (0.6%) | ||
Musculoskeletal pain | 1/158 (0.6%) | 0/157 (0%) | ||
Osteoarthritis | 1/158 (0.6%) | 0/157 (0%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Breast cancer | 0/158 (0%) | 1/157 (0.6%) | ||
Oesophageal carcinoma | 0/158 (0%) | 1/157 (0.6%) | ||
Nervous system disorders | ||||
Brain injury | 0/158 (0%) | 1/157 (0.6%) | ||
Cerebrovascular accident | 1/158 (0.6%) | 1/157 (0.6%) | ||
Dizziness | 1/158 (0.6%) | 0/157 (0%) | ||
Haemorrhagic stroke | 0/158 (0%) | 1/157 (0.6%) | ||
Seizure | 0/158 (0%) | 1/157 (0.6%) | ||
Syncope | 0/158 (0%) | 1/157 (0.6%) | ||
Renal and urinary disorders | ||||
Acute kidney injury | 1/158 (0.6%) | 0/157 (0%) | ||
Anuria | 1/158 (0.6%) | 0/157 (0%) | ||
Chronic kidney disease | 1/158 (0.6%) | 0/157 (0%) | ||
Haemorrhage urinary tract | 0/158 (0%) | 1/157 (0.6%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Aspiration | 0/158 (0%) | 1/157 (0.6%) | ||
Asthma | 1/158 (0.6%) | 0/157 (0%) | ||
Pleural effusion | 1/158 (0.6%) | 0/157 (0%) | ||
Respiratory failure | 0/158 (0%) | 1/157 (0.6%) | ||
Vascular disorders | ||||
Hypertension | 0/158 (0%) | 1/157 (0.6%) | ||
Other (Not Including Serious) Adverse Events |
||||
Placebo | 10 mg Empagliflozin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/158 (0%) | 0/157 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title | Boehringer Ingelheim, Call Centre |
---|---|
Organization | Boehringer Ingelheim |
Phone | 1-800-243-0127 |
clintriage.rdg@boehringer-ingelheim.com |
- 1245-0167
- 2017-004072-59