A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.
- Conditions
- Chronic heart failuredecompensation cordis100192801001842410038430
- Registration Number
- NL-OMON44143
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 141
• Women of childbearing potential can only be included in the study if a pregnancy test is negative at Screening and if they agree to use adequate contraception. Adequate contraception is defined as any 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). Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels >40 mIU/mL [for US only: and estradiol <20 pg/mL] or have had surgical treatment such as bilateral tubal ligation, bilateral ovariectomy, or hysterectomy.;• Diagnosis of CHF, NYHA class II-IV, and documented ejection fraction of <=40%;• Unscheduled emergency presentation to emergency services (outpatient or hospital, including the emergency department ) due to signs and/or symptoms of HF decompensation in the 2 weeks preceding randomization (considered as index event);• Administration of intravenous (IV) decongestive therapy at any time during presentation and/or admission to emergency services for the treatment of the index event;• BNP >400 pg/mL or NT-proBNP >1200 pg/mL in sinus rhythm, and BNP >600 pg/mL or NT-proBNP >1800 pg/mL in atrial fibrillation, at any time starting with the index event, at the latest at screening; ; BNP values are not applicable for subjects taking angiotensin receptor-neprilysin inhibitors (ARNIs);• Type 2 diabetes mellitus (T2DM) in their medical history or at screening ;and/or;Chronic kidney disease (CKD) with moderately reduced kidney function, defined as an estimated glomerular filtration rate (eGFR) between 30 and 60 mL/min/1.73 m² at screening (calculated using the locally approved and validated equation); one reassessment allowed
• Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis, within 3 months prior to randomization;• Acute coronary syndrome, including unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) or ST segment elevation myocardial infarction (STEMI), or major CV surgery including coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy(CRT) device or cardiac contractility modulation (CCM) device, or carotid angioplasty within 3 months prior to randomization;• Stroke or transient ischemic cerebral attack within 3 months prior to randomization;• Cardiogenic shock at randomization, prior to first intake of study drug;• Any primary cause of HF scheduled for surgery , e.g. valve disease such as severe aortic stenosis;• History of heart transplant or need for heart transplantation; presence or need of left ventricular assist device
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Demonstrate the superiority of finerenone to eplerenone in delaying time to<br /><br>first occurrence of the composite<br /><br>endpoint, defined as cardiovascular (CV) death or hospitalization for heart<br /><br>failure (HF), in patients with<br /><br>CHF (NYHA class II-IV) and reduced ejection fraction after recent heart failure<br /><br>decompensation who have<br /><br>additional risk factors, i.e. type 2 diabetes mellitus (T2DM) and/or chronic<br /><br>kidney disease (CKD).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are to determine the superiority of finerenone to<br /><br>eplerenone with regard to the following:<br /><br>Total number of hospitalizations (or equivalent) for HF Delaying the time to<br /><br>first hospitalization (or equivalent)<br /><br>for HF Delaying the time to all-cause mortality Delaying the time to first<br /><br>occurrence of composite renal<br /><br>endpoint: onset of kidney failure, or sustained decrease in estimated<br /><br>glomerular filtration rate (eGFR) >=40%<br /><br>relative to baseline over at least 4 weeks, or renal death.</p><br>