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

Heart Failure Clinical Trial

— REDEFINE-HF  

Official title:

Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008197
• Other study ID #: 202301CPC
• Status: Recruiting
• Phase: Phase 3
• Start date: January 17, 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: Colorado Prevention Center
• Contact: Marc Bonaca
• Phone: 303-860-9900
• Email: info[@]cpcmed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5200
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Finerenone
Oral finerenone
• Placebo
Matching oral placebo

Locations

Country	Name	City	State
United States	Aurora, CO Investigative Site	Aurora	Colorado
United States	Boca Raton, FL Investigative Site	Boca Raton	Florida
United States	Denver, CO Investigative Site	Denver	Colorado
United States	Kansas City, MO Investigative Site	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Colorado Prevention Center	Bayer, Saint Luke's Hospital of Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total hospitalizations for any cause.	Total hospitalizations for any cause with finerenone compared to placebo.	Ongoing, up to ~30 months
Other	Total number of days alive and out of the hospital.	Days alive and out of hospital with finerenone compared to placebo.	Ongoing, up to ~30 months
Other	Number of patients with sustained decrease in eGFR =40% relative to baseline.	Sustained decrease in eGFR =40% relative to baseline with finerenone compared to placebo.	Ongoing, up to ~30 months
Other	Number of patients with sustained eGFR <15 ml/min/1.73 m^2.	Sustained eGFR <15 ml/min/1.73 m^2 with finerenone compared to placebo.	Ongoing, up to ~30 months
Other	Number of patients requiring initiation of dialysis or renal transplant.	Initiation of dialysis or renal transplant with finerenone compared to placebo.	Ongoing, up to ~30 months
Primary	Composite total of HF events and cardiovascular (CV) death.	Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.	Ongoing, up to ~30 months
Primary	Number of serious adverse events.	Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.	Ongoing, up to ~30 months
Primary	Number of adverse events leading to discontinuation of study drug.	Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.	Ongoing, up to ~30 months
Secondary	Time to first occurrence of the composite of CV death or HF event.	Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.	Ongoing, up to ~30 months
Secondary	Total HF events.	Total HF events with finerenone compared to placebo.	Ongoing, up to ~30 months
Secondary	Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.		6 Months
Secondary	Time to CV death.	Time to CV death with finerenone compared to placebo.	Ongoing, up to ~30 months
Secondary	Time to death from any cause.	Time to death from any cause with finerenone compared to placebo.	Ongoing, up to ~30 months