Phase 2
Completed N=1,066
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
Source: ClinicalTrials.gov NCT01807221 ↗Enrolled (actual)
1,066
Serious AEs
33.3%
Results posted
Jun 2021
Primary outcomePrimary: Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 — 37.2; 30.9; 32.5; 37.3 Percentage of participants — p=0.8771
Summary
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 |
37.2; 30.9; 32.5; 37.3; 38.8; 34.2 | 0.8771 |
| SECONDARY Number of Participants With Death Due to Any Cause |
6; 5; 1; 1; 0; 2 | — |
| SECONDARY Number of Participants With Cardiovascular Hospitalization |
28; 23; 14; 8; 7; 15 | — |
| SECONDARY Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) |
21; 19; 12; 9; 7; 15 | — |
| SECONDARY Ratio of BNP at Specified Visits to BNP at Baseline |
0.925; 0.944; 0.878; 0.832; 0.852; 0.879 | — |
| SECONDARY Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline |
0.883; 0.98; 0.874; 0.888; 0.822; 0.921 | — |
| SECONDARY Change From Baseline in KCCQ Questionnaire Scores at Specified Visits |
43.7; 42.8; 45.4; 42.1; 42.3; 43.2 | — |
| SECONDARY Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits |
0.58; 0.59; 0.62; 0.58; 0.56; 0.59 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
- Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
- Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
- Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
- Subjects with type 2 diabetes mellitus and / or
- Subjects with 30 mL/min/1.73m^2 /= 90 mmHg without signs and symptoms of hypotension at the screening visit
Exclusion Criteria
- Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
- Acute coronary syndrome (ACS) in last 30 days prior to screening
- Cardiogenic shock
- Valvular heart disease requiring surgical intervention during the course of the study
- Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
- Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic
Data sourced from ClinicalTrials.gov (NCT01807221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.