Clinical trial NCT06008197: A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Heart Failure
Acute Heart Failure
Keywords: Heart failure
Preserved ejection fraction
Mildly reduced ejection fraction
Hospitalized
Lead sponsor: Colorado Prevention Center
Sponsor class: OTHER
Collaborators: name: St. Luke's Hospital, Kansas City, Missouri
name: Bayer
First posted: 2023-08-23
Enrollment: 5200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite total of HF events and cardiovascular (CV) death.
timeFrame: Ongoing, up to ~30 months
measure: Number of serious adverse events.
timeFrame: Ongoing, up to ~30 months
measure: Number of adverse events leading to discontinuation of study drug.
timeFrame: Ongoing, up to ~30 months
Secondary outcomes:
measure: Time to first occurrence of the composite of CV death or HF event.
timeFrame: Ongoing, up to ~30 months
measure: Total HF events.
timeFrame: Ongoing, up to ~30 months
measure: Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
timeFrame: 6 Months
measure: Time to CV death.
timeFrame: Ongoing, up to ~30 months
measure: Time to death from any cause.
timeFrame: Ongoing, up to ~30 months
Other outcomes:
measure: Total hospitalizations for any cause.
timeFrame: Ongoing, up to ~30 months
measure: Total number of days alive and out of the hospital.
timeFrame: Ongoing, up to ~30 months
measure: Number of patients with sustained decrease in eGFR ≥40% relative to baseline.
timeFrame: Ongoing, up to ~30 months
measure: Number of patients with sustained eGFR <15 ml/min/1.73 m^2.
timeFrame: Ongoing, up to ~30 months
measure: Number of patients requiring initiation of dialysis or renal transplant.
timeFrame: Ongoing, up to ~30 months
Locations:
city: Aurora
country: United States
facility: Aurora, CO Investigative Site
state: Colorado
city: Denver
country: United States
facility: Denver, CO Investigative Site
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton, FL Investigative Site
state: Florida
city: Kansas City
country: United States
facility: Kansas City, MO Investigative Site
state: Missouri
Study officials:
References: