A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)

Colorado Prevention Center Clinical Research

Status and phase

Enrolling

Phase 3

Conditions

Heart Failure

Treatments

Drug: Finerenone

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06033950

202304CPC

Details and patient eligibility

About

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Full description

This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.

Enrollment

2,600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
Symptomatic HFrEF per protocol defined criteria
Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment
Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Exclusion criteria

Treatment with non-steroidal MRA (nsMRA)
Documented prior history of severe hyperkalemia in the setting of MRA use
eGFR < 25 mL/min/1.73m² and / or potassium > 5.0 mmol/L
Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned
Prior or planned heart transplant
Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure
Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
Probable alternative cause of participant's HF
Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers
Known hypersensitivity to the IP (active substance or excipients)
Any other condition or therapy which would make the participant unsuitable for the study
Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization