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

Description

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).

Conditions

Heart Failure

Study Overview

Study Details

Study overview

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).

A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Fairhope

FIN-10004 Fairhope, AL Investigational Site, Fairhope, Alabama, United States, 36532

San Diego

FIN-10075 San Diego, CA Investigational Site, San Diego, California, United States, 92243

Kansas City

FIN-10002 Kansas City, MO Investigational Site, Kansas City, Missouri, United States, 64111

Austin

FIN-10015 Austin, TX Investigational Site, Austin, Texas, United States, 78705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Colorado Prevention Center,

Study Record Dates

2028-04