Subjects 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 MedDRA version: 18.0 Level: LLT Classification code 10076410 Term: Chronic kidney disease stage 3 System Organ Class: 100000004857 MedDRA version: 18.0 Level: LLT Cla
Conditions
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1944 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3946
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the composite endpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients with chronic heart failure (CHF) (NYHA class II–IV) and reduced ejection fraction after recent heart failure decompensation who have additional risk factors, i.e. type 2 diabetes mellitus (T2DM) and/or or chronic kidney disease (CKD).; Secondary Objective: The secondary objectives of this study are to determine the superiority of finerenone to eplerenone with regard to the following: • Total number of hospitalizations (or equivalent) for HF • Time to first hospitalization (or equivalent) for HF • All-cause mortality • Time to first occurrence of composite renal endpoint: onset of kidney failure, or sustained decrease in estimated glomerular filtration rate (eGFR) =40% relative to baseline over at least 4 weeks, or renal death. ; Primary end point(s): Time to the first occurrence of the primary composite endpoint, consisting of the following components: - CV death - Hospitalization for HF ;Timepoint(s) of evaluation of this end point: From randomization (Visit 1) until the end of study following the study termination decision, approximately from 18 to 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables will be as follows: • Total number of hospitalizations (or equivalent) for HF •Time to first hospitalization (or equivalent) for HF •Time to all-cause mortality •Time to first occurrence of composite renal endpoint: o Onset of kidney failure o Sustained decrease in eGFR =40% relative to baseline over at least 4 weeks o Renal death ;Timepoint(s) of evaluation of this end point: From randomization (Visit 1) until the end of study following the study termination decision, approximately from 18 to 36 months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States, Vietnam
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed