Efficacy and safety of finerenone in subjects with chronic heart failure at high risk of recurrent heart failure decompensatio

Phase 1

• Conditions: 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: 18.1 Level: LLT Classification code 10076410 Term: Chronic kidney disease stage 3 System Organ Class: 100000004857; MedDRA version: 18.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861; MedDRA version: 18.1 Level: LLT Classification code 10066498 Term: Cardiac failure chronic aggravated System Organ Class: 100000004849; MedDRA version: 18.1 Level: LLT Classification code 10076408 Term: Chronic kidney disease stage 1 System Organ Class: 100000004857; MedDRA version: 18.1 Level: LLT Classification code 10076409 Term: Chronic kidney disease stage 2 System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002168-17-GR
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5890

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 <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

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

• 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 clinical trial of medicinal product
• Study Design: Not specified