A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Key facts
- Where
- Aparecida de Goiânia, Aracaju, Arapiraca, Atibaia, Belo Horizonte, Bragança Paulista, Brasília, Campinas, Caxias do Sul, Curitiba, Fortaleza, Goiânia, Itaquera, Joinville, Linhares, Londrina, Natal, Osasco, Passo Fundo, Poços de Caldas, Porto Alegre, Porto Velho, Presidente Prudente, Recife, Rio Branco, Rio de Janeiro, Salvador, Santo André, São Carlos, São José, São José dos Campos, São Paulo, Teresina, Vila Velha és Votuporanga, BrazíliaSee the 55 sites
- Phase
- 3. fázis
Where in Brazília
- Aparecida de Goiânia, Goiás Investigative Site 21053Aparecida de Goiânia, BrazíliaTaking people
- AracajuAracaju, BrazíliaTaking people
- AracajuAracaju, BrazíliaTaking people
- ArapiracaArapiraca, BrazíliaTaking people
- AtibaiaAtibaia, BrazíliaTaking people
- Belo HorizonteBelo Horizonte, BrazíliaTaking people
- Belo HorizonteBelo Horizonte, BrazíliaTaking people
- Belo HorizonteBelo Horizonte, BrazíliaTaking people
- Belo HorizonteBelo Horizonte, BrazíliaTaking people
- Bragança PaulistaBragança Paulista, BrazíliaTaking people
- BrasíliaBrasília, BrazíliaTaking people
- CampinasCampinas, BrazíliaTaking people
- Caxias do Sul, Rio Grande do Sull Investigative Site 21008Caxias do Sul, BrazíliaTaking people
- CuritibaCuritiba, BrazíliaTaking people
- CuritibaCuritiba, BrazíliaTaking people
- CuritibaCuritiba, BrazíliaTaking people
- FortalezaFortaleza, BrazíliaNo longer taking part
- GoiâniaGoiânia, BrazíliaTaking people
- ItaqueraItaquera, BrazíliaTaking people
- JoinvilleJoinville, BrazíliaTaking people
- Centro Linhares, Espirito Santo Investigative Site 21017Linhares, BrazíliaTaking people
- LondrinaLondrina, BrazíliaTaking people
- Natal, Rio Grande do Norte Investigative Site 21024Natal, BrazíliaTaking people
- OsascoOsasco, BrazíliaTaking people
- Passo Fundo, Rio Grande do Sul Investigative Site 21042Passo Fundo, BrazíliaTaking people
- Poços de Caldas, Minas Gerais Investigative Site 21009Poços de Caldas, BrazíliaTaking people
- Porto AlegrePorto Alegre, BrazíliaTaking people
- Porto AlegrePorto Alegre, BrazíliaTaking people
- Porto Alegre, Rio Grande do Sul Investigative Site 21025Porto Alegre, BrazíliaTaking people
- Porto VelhoPorto Velho, BrazíliaTaking people
- Presidente PrudentePresidente Prudente, BrazíliaTaking people
- RecifeRecife, BrazíliaTaking people
- RecifeRecife, BrazíliaTaking people
- RecifeRecife, BrazíliaTaking people
- Rio BrancoRio Branco, BrazíliaTaking people
- Rio de Janeiro Investigative Site 21034Rio de Janeiro, BrazíliaTaking people
- Rio De Janeiro, Rio De Janeiro Investigative Site 21016Rio de Janeiro, BrazíliaTaking people
- SalvadorSalvador, BrazíliaTaking people
- Santo AndréSanto André, BrazíliaToborzás még nem indult
- São CarlosSão Carlos, BrazíliaTaking people
- São JoséSão José, BrazíliaTaking people
- São José Dos Campos, Sao Paulo Investigative Site 21012São José dos Campos, BrazíliaTaking people
- São José dos Campos, São Paulo Investigative Site 21081São José dos Campos, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- São PauloSão Paulo, BrazíliaTaking people
- TeresinaTeresina, BrazíliaTaking people
- Vila VelhaVila Velha, BrazíliaTaking people
- VotuporangaVotuporanga, BrazíliaTaking 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
- NCT06008197
- Record updated
- 2026. szeptember 10.
- Original description
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.Read full original descriptionShow less
Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
Inclusion: Provide written informed consent; Age ≥18 years or legal age of majority if >18 years in the participant's country of residence; Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure; Heart failure signs and symptoms at the time of hospital admission; Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher); Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF.
Exclusion: Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA); Documented prior history of severe hyperkalemia in the setting of MRA use; Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers; Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days; Hemodynamically significant (severe) uncorrected primary cardiac valvular disease; Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction; Probable alternative cause of participant's heart failure symptoms; Known hypersensitivity to the IP (active substance or excipients); Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or potassium >5.0 mmol/L at screening.