Recruiting NCT06033950

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

Phase III Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Finerenone, Placebo.
Who it may be relevant to: Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Canada, Croatia +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

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).

Detailed description

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

Interventions

Drug Finerenone
Oral finerenone.
Drug Placebo
Matching oral placebo.

Primary outcome measures

Time to first occurrence of cardiovascular (CV) death or HF event. [Time frame: Ongoing, up to ~30 months]
Number of serious adverse events [Time frame: Ongoing, up to ~30 months]
Number of adverse events leading to discontinuation of study drug. [Time frame: Ongoing, up to ~30 months]

Secondary outcome measures (5)

Timing and occurrence of total CV deaths and HF events [Time frame: Ongoing, up to ~30 months]
Timing and occurrence of total HF events [Time frame: Ongoing, up to ~30 months]
Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6. [Time frame: 180 days]
Time to CV death. [Time frame: Ongoing, up to ~30 months]
Time to all-cause death. [Time frame: Ongoing, up to ~30 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 54 centers

FIN-10004 Fairhope, AL Investigational Site — Fairhope
Phoenix, AZ Investigative Site FIN-10115 — Phoenix
FIN-10401, Yuma, AZ — Yuma
Chula Vista, CA Investigative Site FIN-10419 — Chula Vista
Chula Vista, CA Investigative Site FIN-10111 — Chula Vista
FIN-10407, Northridge, CA — Northridge
FIN-10412, Orange, CA — Orange
FIN-10070, Pamona, CA — Pomona
… and 46 more centers

Brazil · 44 centers

FIN-21063, Rio Branco, Acre — Rio Branco
FIN-21078, Maceió, Alagoas — Maceió
FIN-21072 Salvador, Bahia - BA — Salvador
Fortaleza, Ceará Investigative Site'FIN-21076 — Fortaleza
Fortaleza, Ceará Investigative Site FIN-21055 — Fortaleza
FIN-21032, Salvador, Bahia — Salvador
FIN-21028, Brasilia, Distrito Federal — Brasília
FIN-21053, Aparecida de Goiânia, Goiás — Aparecida de Goiânia
… and 36 more centers

Canada · 14 centers