Finerenone Compared With Placebo in Heart Failure Patients
Tests finerenone against placebo in adults with reduced-ejection-fraction heart failure who cannot take steroidal drugs.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Aparecida de Goiânia, Aracaju, Belo Horizonte, Bragança Paulista, Brasília, Campinas, Caxias do Sul, Curitiba, Fortaleza, Goiânia, Guarulhos, Itaquera, Joinville, Londrina, Maceió, Natal, Osasco, Porto Alegre, Presidente Prudente, Recife, Rio Branco, Rio de Janeiro, Salvador, Santo André, São Carlos, São José dos Campos, São Paulo, Teresina, and Votuporanga, BrazilSee the 44 sites
- Phase
- Phase 3
Where in Brazil
- FIN-21053, Aparecida de Goiânia, GoiásAparecida de Goiânia, BrazilTaking people
- FIN-21058, Aracaju, SergipeAracaju, BrazilTaking people
- Belo Horizonte, Minas GeraisBelo Horizonte, BrazilTaking people
- Belo Horizonte, Minas Gerais Investigative Site FIN-21079Belo Horizonte, BrazilTaking people
- FIN-21013, Belo Horizonte, Minas GeraisBelo Horizonte, BrazilTaking people
- FIN-21051, Belo Horizonte, Minas GeraisBelo Horizonte, BrazilTaking people
- FIN-21071, Belo Horizonte, Minas GeraisBelo Horizonte, BrazilTaking people
- FIN-21004 Braganca Paulista, Sao PauloBragança Paulista, BrazilTaking people
- FIN-21028, Brasilia, Distrito FederalBrasília, BrazilTaking people
- Campinas, São Paulo Investigative Site' FIN-21083Campinas, BrazilTaking people
- FIN-21008, Caxias do Sul, Rio Grande do SulCaxias do Sul, BrazilTaking people
- FIN-21056, Curitiba, ParanáCuritiba, BrazilTaking people
- Fortaleza, Ceará Investigative Site FIN-21055Fortaleza, BrazilTaking people
- Fortaleza, Ceará Investigative Site'FIN-21076Fortaleza, BrazilTaking people
- GoiâniaGoiânia, BrazilTaking people
- FIN-21068, Guarulhos, São PauloGuarulhos, BrazilTaking people
- FIN-21005, Itaquera, São PauloItaquera, BrazilTaking people
- FIN-21007, Joinville, Santa CatarinaJoinville, BrazilTaking people
- FIN-21047, Londrina, ParanáLondrina, BrazilTaking people
- FIN-21078, Maceió, AlagoasMaceió, BrazilTaking people
- FIN-21024, Natal, Rio Grande do NorteNatal, BrazilTaking people
- FIN-21010, Osasco, São PauloOsasco, BrazilTaking people
- FIN-21019, Porto Alegre, Rio Grande do SulPorto Alegre, BrazilTaking people
- FIN-21011, Presidente Prudente, São PauloPresidente Prudente, BrazilTaking people
- FIN-21001, Recife, RecifeRecife, BrazilTaking people
- FIN-21021, Recife, PernambucoRecife, BrazilTaking people
- FIN-21061, Recife, PernambucoRecife, BrazilTaking people
- Recife, Pernambuco Investigative Site FIN-21086Recife, BrazilTaking people
- FIN-21063, Rio Branco, AcreRio Branco, BrazilTaking people
- FIN-21014, Rio de Janeiro, Rio de JaneiroRio de Janeiro, BrazilTaking people
- FIN-21016, Rio De Janeiro, Rio De JaneiroRio de Janeiro, BrazilTaking people
- Rio de Janeiro Investigative Site FIN-21034Rio de Janeiro, BrazilTaking people
- FIN-21032, Salvador, BahiaSalvador, BrazilTaking people
- FIN-21072 Salvador, Bahia - BASalvador, BrazilTaking people
- FIN-21043, Santo André, São PauloSanto André, BrazilTaking people
- São Carlos, São Paulo Investigative Site FIN-21075São Carlos, BrazilTaking people
- São José dos Campos, São Paulo Investigative Site'FIN-21081São José dos Campos, BrazilTaking people
- FIN-21037, São Paulo, São PauloSão Paulo, BrazilTaking people
- FIN-21048, São Paulo, São PauloSão Paulo, BrazilTaking people
- FIN-21049 Sao Paulo, Sao PauloSão Paulo, BrazilTaking people
- FIN-21074, São Paulo, São PauloSão Paulo, BrazilTaking people
- São Paulo Investigative Site FIN-21066São Paulo, BrazilTaking people
- Teresina, Piaui Investigative Site FIN-21050Teresina, BrazilTaking people
- FIN-21031, Votuporanga, São PauloVotuporanga, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Colorado Prevention Center
- Trial code
- NCT06033950
- Record updated
- 10 July 2026
- Original 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).Read full original descriptionShow less
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)
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).
Inclusion: 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: Treatment with non-steroidal MRA (nsMRA); Documented prior history of severe hyperkalemia in the setting of MRA use; Prior or planned heart transplant; Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers; Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization; Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned; 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; Known hypersensitivity to the IP (active substance or excipients); Any other condition or therapy which would make the participant unsuitable for the study; eGFR < 25 mL/min/1.73m² and / or potassium > 5.0 mmol/L; Probable alternative cause of participant's HF.