A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

What this study is about

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Who can join (things the study team will check)

✅ You may be able to join if…

• Provide written informed consent
• Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
• Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
• Heart failure signs and symptoms at the time of hospital admission
• Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
• Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF

🚫 You may not be able to join if…

• Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
• Documented prior history of severe hyperkalemia in the setting of MRA use
• Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or potassium >5.0 mmol/L at screening
• Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
• Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
• Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction
• Probable alternative cause of participant's heart failure symptoms
• Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
• Known hypersensitivity to the IP (active substance or excipients)

Where this trial is running

• Birmingham, AL Investigative Site 10012, Birmingham, Alabama, United States
• Fairhope, AL Investigative Site 10004, Fairhope, Alabama, United States
• Huntsville, AL Investigative Site 10026, Huntsville, Alabama, United States
• Glendale, AZ Investigative Site 10096, Glendale, Arizona, United States
• Phoenix, AZ Investigative Site 10115, Phoenix, Arizona, United States
• Scottsdale, AZ Investigative Site 10003, Scottsdale, Arizona, United States
• Chula Vista, CA Investigative Site 10111, Chula Vista, California, United States
• Huntington Beach, CA Investigative Site 10031, Huntington Beach, California, United States
• Los Angeles, CA Investigative Site 10089, Los Angeles, California, United States
• Sacramento, CA Investigative Site 10024, Sacramento, California, United States
• San Francisco, CA Investigative Site 10023, San Francisco, California, United States
• Tarzana, CA Investigative Site 10409, Tarzana, California, United States

+ 303 more sites.

Who to contact

Marc Bonaca · 303-860-9900 · info@cpcmed.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06008197.