NCT06033950

A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists

A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,600 (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 with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Detailed description

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

Conditions

• Heart Failure

Interventions

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

Timeline

• Start date: 2024-08-20
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2023-09-13
• Last updated: 2025-03-11

Locations

8 sites across 3 countries: United States, Brazil, Canada

Regulatory

• FDA-regulated drug study