Last updated 45 days ago
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
2600 patients around the world
Available in Brazil, United States
This is an international, randomized, double-blind, placebo-controlled trial of
finerenone for the treatment of heart failure patients with reduced ejection fraction.
Colorado Prevention Center
2600Patients around the world
This study is for people with
Heart failure
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
StudyFINALITY-HF
SponsorColorado Prevention Center
Study typeInterventional
Conditions
Heart failure
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06033950
