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: 18.0Level: LLTClassification code 10076410Term: Chronic kidney disease stage 3System Organ Class: 100000004857
MedDRA version: 18.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
MedDRA version: 18.0Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 100000004849
MedDRA version: 18.0Level: LLTClassification code 10076408Term: Chronic kidney disease stage 1System Organ Class: 100000004857
MedDRA version: 18.0Level: LLTClassification code 10076409Term: Chronic kidney disease stage 2System Organ Class: 100000004857
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-002168-17-GB

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5890

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be included in the study:
1. Written informed consent signed before any study-specific procedure
2. Men or women aged 18 years and older. The lower age limit may be higher if legally requested in the participating country
3. 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.
4. Diagnosis of CHF, NYHA class II-IV, and documented ejection fraction of =40%
5. 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)
6. Administration of intravenous (IV) decongestive therapy at any time during presentation and/or admission to emergency services for the treatment of the index event
7. 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)
8. 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
9. Standard HF treatment with life-saving medications (e.g. an angiotensin-converting enzyme inhibitor [ACEI] or angiotensin receptor blocker [ARB] and beta-blockers), unless contraindicated or not tolerated, for at least 4 weeks prior to the index event of worsening HF and in accordance with standard local therapy guidelines

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

Subjects who meet any of the following criteria will be excluded from the study:
Medical and surgical history/conditions
1. Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis, within 3 months prior to randomization
2. 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
3. Stroke or transient ischemic cerebral attack within 3 months prior to randomization
4. Cardiogenic shock at randomization, prior to first intake of study drug
5. Symptomatic hypotension with systolic blood pressure <90 mmHg at randomization
6. Any primary cause of HF scheduled for surgery , e.g. valve disease such as severe aortic stenosis
7. History of heart transplant or need for heart transplantation; presence or need of left ventricular assist device
8. History of hyperkalemia or acute renal failure during MRA treatment for >7 consecutive days, leading to permanent discontinuation of the MRA treatment
9. eGFR <30 mL/min/1.73 m² within 24 hours prior to randomization; one reassessment allowed
10. Serum/plasma potassium >5.0 mmol/L within 24 hours prior to randomization; one reassessment allowed
11. Known hypersensitivity to the study drug (active substance or excipients) or eplerenone
12. Hepatic insufficiency classified as Child-Pugh C
13. Addison’s disease.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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