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

Last updated: February 29, 2024
Sponsor: Colorado Prevention Center
Overall Status: Active - Recruiting

Phase

3

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

Placebo

Finerenone

Clinical Study ID

NCT06008197
202301CPC
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provide electronic or written informed consent, either personally or through a legallyauthorized representative
  • Age ≥18 years
  • Current hospitalization or recently discharged with the primary diagnosis of heartfailure
  • 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-typenatriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); orelevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF

Exclusion

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/plasmapotassium >5.0 mmol/L at screening
  • Acute myocardial infarction, coronary revascularization, valve replacement/repair, orimplantation 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, orknown 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 Design

Total Participants: 5200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 17, 2024
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Aurora, CO Investigative Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Denver, CO Investigative Site

    Denver, Colorado 80204
    United States

    Site Not Available

  • Boca Raton, FL Investigative Site

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Kansas City, MO Investigative Site

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

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