What is finerenone studying for heart failure in this clinical trial?

Finerenone is being studied to evaluate its effects on morbidity and mortality in patients hospitalized with acute decompensated heart failure and mildly reduced or preserved ejection fraction. Researchers want to know whether finerenone can improve outcomes compared to a placebo. The trial is sponsored by the Colorado Prevention Center and follows a strict study design to ensure reliable results.

Who may be eligible for this heart failure clinical trial?

Adults aged 18 years or older who are currently hospitalized or recently discharged with acute heart failure and have a left ventricular ejection fraction of 40% or higher may be eligible. Both men and women can participate. Key factors include elevated heart failure markers and no current long-term use of certain heart medications. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06008197

Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction 40 Hospitalized for Acute Decompensated Heart Failure

Led by Colorado Prevention Center · Updated on 2026-05-06

5200

Participants Needed

299

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international study is a randomized, double-blind, placebo-controlled trial designed to assess how finerenone affects morbidity and mortality in these patients. Participants are randomly assigned to receive either oral finerenone or a matching placebo. The study is event-driven and ongoing for up to about 30 months, focusing on heart failure events and cardiovascular deaths. The trial includes careful monitoring of adverse events and treatment discontinuation due to side effects. During the study, participants will be closely monitored for heart failure events, cardiovascular deaths, and changes in symptoms using the Kansas City Cardiomyopathy Questionnaire. Regular assessments will track serious adverse events and safety. The total duration of participation may last up to approximately 30 months, with ongoing follow-up to understand long-term effects of the treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Provide written informed consent
Age 18 years or older (or legal age of majority in participant's country)
Currently hospitalized or recently discharged (within 30 days) with primary diagnosis of heart failure
Heart failure signs and symptoms at hospital admission
Imaging shows left ventricular ejection fraction 40% or higher
Elevated NTproBNP ≥500 pg/mL or BNP ≥125 pg/mL if no atrial fibrillation; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL if atrial fibrillation

You will not qualify if you...

Current or planned long-term treatment with mineralocorticoid receptor antagonist (MRA)
Prior history of severe hyperkalemia while using MRA
Estimated glomerular filtration rate below 25 mL/min/1.73m² or potassium above 5.0 mmol/L at screening
Acute myocardial infarction, coronary revascularization, valve surgery, or cardiac device implantation within 30 days
Severe uncorrected primary cardiac valvular disease
Cardiomyopathy due to acute inflammatory, infiltrative diseases, muscular dystrophies, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
Alternative probable cause for heart failure symptoms
Use of potent CYP3A4 inhibitors or inducers
Known allergy to the study drug or its components

Research Team

Marc Bonaca

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