Evaluating Finerenone for Heart Failure Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of finerenone in hospitalized patients with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. Participants will receive either finerenone or a placebo while being monitored for morbidity and mortality outcomes. The study focuses on patients with specific heart failure symptoms and elevated biomarkers, ensuring a targeted approach to treatment. The trial is designed to provide robust data on the potential benefits of finerenone in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Birmingham, AL Investigative Site 10012
  Birmingham, Alabama, United States Recruiting
• Fairhope, AL Investigative Site 10004
  Fairhope, Alabama, United States Recruiting
• Huntsville, AL Investigative Site 10026
  Huntsville, Alabama, United States Recruiting
• Glendale, AZ Investigative Site 10096
  Glendale, Arizona, United States Recruiting
• Phoenix, AZ Investigative Site 10115
  Phoenix, Arizona, United States Recruiting
• Scottsdale, AZ Investigative Site 10003
  Scottsdale, Arizona, United States Recruiting

+306 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Marc Bonaca
• Email: info@cpcmed.org
• Phone: 303-860-9900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.