A randomized, double-blind, double-dummy, multi-center study to assess safety and efficacy of BAY 94-8862 in subjects with emergency presentation at the hospital because of worsening chronic heart failure with left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease alone versus eplerenone
- Conditions
- heart failure - insufficient heart pumping100384301001928010012653
- Registration Number
- NL-OMON40147
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 69
• Men and women aged 18 years and older. The lower age limit may be higher if legally requested 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. Adequate contraception is defined as a combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices)
• Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital;• Subjects with clinical diagnosis of CHF either ischemic or non ischemic, NYHA functional class II -IV;• Subjects with type 2 diabetes mellitus ;and / or;Subjects with 30 mL/min/1.73m2 < or = eGFR < or = 60 mL/min/1.73m2 (MDRD)(23) at screening ;• Left ventricular ejection fraction (LVEF) < or = 40%;• Blood potassium <= 5.0 mmol/L at screening ;• Systolic blood pressure > or = 90 mmHg without signs and symptoms of hypotension at the screening visit
• Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis;• Acute coronary syndrome (ACS) in the 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 MRA, renin inhibitor, or potassium-sparing diuretic
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Relative decrease in N-terminal prohormone B-type natriuretic peptide<br /><br>(NT-proBNP). From baseline to 90 days.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change in blood potassium From baseline<br /><br>to 90 days<br /><br><br /><br>Change in blood pressure From<br /><br>baseline to 90 days<br /><br><br /><br>Change in heart rate From<br /><br>baseline to 90 days<br /><br><br /><br>Number of participants with adverse events as a<br /><br>measure of safety and tolerability Up to 120<br /><br>days</p><br>