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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Acute Heart Failure

In brief

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.

Key facts

Study ID

NCT06008197

Run by

Colorado Prevention Center

People needed

5200

Starts

2024-01-17

Expected to finish

2027-12-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Fairhope, AL Investigative Site 10004 — Fairhope, Alabama, United States (enrolling)
• Birmingham, AL Investigative Site 10012 — Birmingham, Alabama, United States (enrolling)
• Glendale, AZ Investigative Site 10096 — Glendale, Arizona, United States (enrolling)
• Phoenix, AZ Investigative Site 10115 — Phoenix, Arizona, United States (enrolling)
• Huntsville, AL Investigative Site 10026 — Huntsville, Alabama, United States (enrolling)
• Chula Vista, CA Investigative Site 10111 — Chula Vista, California, United States (enrolling)
• Huntington Beach, CA Investigative Site 10031 — Huntington Beach, California, United States (enrolling)
• Los Angeles, CA Investigative Site 10089 — Los Angeles, California, United States (enrolling)
• Sacramento, CA Investigative Site 10024 — Sacramento, California, United States (enrolling)
• San Francisco, CA Investigative Site 10023 — San Francisco, California, United States (enrolling)
• Scottsdale, AZ Investigative Site 10003 — Scottsdale, Arizona, United States (enrolling)
• Van Nuys, CA Investigative Site 10109 — Van Nuys, California, United States (enrolling)
• West Hills, CA Investigative Site 10013 — West Hills, California, United States (enrolling)
• Aurora, CO Investigative Site 10001 — Aurora, Colorado, United States (enrolling)
• Denver, CO Investigative Site 10005 — Denver, Colorado, United States (enrolling)
• Bradenton, FL Investigative Site 10125 — Bradenton, Florida, United States (enrolling)
• Brooksville, FL Investigative Site 10077 — Brooksville, Florida, United States (enrolling)
• Fort Lauderdale, FL Investigative Site 10114 — Fort Lauderdale, Florida, United States (enrolling)
• Fort Myers, FL Investigative Site 10076 — Fort Myers, Florida, United States (enrolling)
• Hialeah, FL Investigative Site 10104 — Hialeah, Florida, United States (enrolling)
• Jacksonville, FL Investigative Site 10028 — Jacksonville, Florida, United States (enrolling)
• Miami, FL Investigative Site 10105 — Miami, Florida, United States (enrolling)
• Miami, FL Investigative Site 10040 — Miami, Florida, United States (enrolling)
• Tarzana, CA Investigative Site 10409 — Tarzana, California, United States (enrolling)
• Atlanta, GA Investigative Site 10022 — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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