Heart Failure Clinical Trial

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

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.

View Full Description

Full Description

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Provide electronic or written informed consent, either personally or through a legally authorized representative
Age ≥18 years
Current hospitalization or recently discharged 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) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF

Exclusion Criteria:

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 serum/plasma potassium >5.0 mmol/L at screening
Acute myocardial infarction, 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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

5200

Study ID:

NCT06008197

Recruitment Status:

Recruiting

Sponsor:

Colorado Prevention Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 4 Locations for this study

See Locations Near You

Aurora, CO Investigative Site
Aurora Colorado, 80045, United States More Info
Marc Bonaca
Contact
Denver, CO Investigative Site
Denver Colorado, 80204, United States More Info
Marc Bonaca
Contact
Boca Raton, FL Investigative Site
Boca Raton Florida, 33434, United States More Info
Marc Bonaca
Contact
Kansas City, MO Investigative Site
Kansas City Missouri, 64111, United States More Info
Marc Bonaca
Contact

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

5200

Study ID:

NCT06008197

Recruitment Status:

Recruiting

Sponsor:


Colorado Prevention Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.