NCT06008197

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

Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,200 (estimated)
• Sponsor: Colorado Prevention Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.

Conditions

• Heart Failure
• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Finerenone	Oral finerenone
DRUG	Placebo	Matching oral placebo

Timeline

• Start date: 2024-01-17
• Primary completion: 2027-11-01
• Completion: 2027-12-01
• First posted: 2023-08-23
• Last updated: 2026-02-20

Locations

80 sites across 18 countries: United States, Argentina, Australia, Brazil, Canada, Croatia, Czechia, Germany, Greece, India, Italy, Lithuania, Malaysia, Mexico, Peru, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study