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

Phase 3

Recruiting

• Conditions: Heart Failure; Acute Heart Failure
• Interventions: Drug: Finerenone; Drug: Placebo

• Registration Number: NCT06008197
• Lead Sponsor: Colorado Prevention Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-23
• Study Start: 2024-01-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Finerenone	Finerenone	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Composite total of HF events and cardiovascular (CV) death.	Ongoing, up to ~30 months	Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
Number of serious adverse events.	Ongoing, up to ~30 months	Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Number of adverse events leading to discontinuation of study drug.	Ongoing, up to ~30 months	Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.

Secondary Outcome Measures

Name	Time	Method
Time to first occurrence of the composite of CV death or HF event.	Ongoing, up to ~30 months	Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
Total HF events.	Ongoing, up to ~30 months	Total HF events with finerenone compared to placebo.
Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.	6 Months
Time to CV death.	Ongoing, up to ~30 months	Time to CV death with finerenone compared to placebo.
Time to death from any cause.	Ongoing, up to ~30 months	Time to death from any cause with finerenone compared to placebo.

Trial Locations

Locations (4)

Aurora, CO Investigative Site; 🇺🇸 Aurora, Colorado, United States

Denver, CO Investigative Site; 🇺🇸 Denver, Colorado, United States

Boca Raton, FL Investigative Site; 🇺🇸 Boca Raton, Florida, United States

Kansas City, MO Investigative Site; 🇺🇸 Kansas City, Missouri, United States