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Taking people in BrazilPhase 3

Tests finerenone in people hospitalized with heart failure and preserved heart pumping

Compares finerenone with placebo in adults hospitalized for acute decompensated heart failure.

Plain-language title generated from the registry record
Registry title: 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, and Votuporanga, BrazilSee the 55 sites
Phase
Phase 3

Where in Brazil

  • Aparecida de Goiânia, Goiás Investigative Site 21053Aparecida de Goiânia, BrazilTaking people
  • AracajuAracaju, BrazilTaking people
  • AracajuAracaju, BrazilTaking people
  • ArapiracaArapiraca, BrazilTaking people
  • AtibaiaAtibaia, BrazilTaking people
  • Belo HorizonteBelo Horizonte, BrazilTaking people
  • Belo HorizonteBelo Horizonte, BrazilTaking people
  • Belo HorizonteBelo Horizonte, BrazilTaking people
  • Belo HorizonteBelo Horizonte, BrazilTaking people
  • Bragança PaulistaBragança Paulista, BrazilTaking people
  • BrasíliaBrasília, BrazilTaking people
  • CampinasCampinas, BrazilTaking people
  • Caxias do Sul, Rio Grande do Sull Investigative Site 21008Caxias do Sul, BrazilTaking people
  • CuritibaCuritiba, BrazilTaking people
  • CuritibaCuritiba, BrazilTaking people
  • CuritibaCuritiba, BrazilTaking people
  • FortalezaFortaleza, BrazilNo longer taking part
  • GoiâniaGoiânia, BrazilTaking people
  • ItaqueraItaquera, BrazilTaking people
  • JoinvilleJoinville, BrazilTaking people
  • Centro Linhares, Espirito Santo Investigative Site 21017Linhares, BrazilTaking people
  • LondrinaLondrina, BrazilTaking people
  • Natal, Rio Grande do Norte Investigative Site 21024Natal, BrazilTaking people
  • OsascoOsasco, BrazilTaking people
  • Passo Fundo, Rio Grande do Sul Investigative Site 21042Passo Fundo, BrazilTaking people
  • Poços de Caldas, Minas Gerais Investigative Site 21009Poços de Caldas, BrazilTaking people
  • Porto AlegrePorto Alegre, BrazilTaking people
  • Porto AlegrePorto Alegre, BrazilTaking people
  • Porto Alegre, Rio Grande do Sul Investigative Site 21025Porto Alegre, BrazilTaking people
  • Porto VelhoPorto Velho, BrazilTaking people
  • Presidente PrudentePresidente Prudente, BrazilTaking people
  • RecifeRecife, BrazilTaking people
  • RecifeRecife, BrazilTaking people
  • RecifeRecife, BrazilTaking people
  • Rio BrancoRio Branco, BrazilTaking people
  • Rio de Janeiro Investigative Site 21034Rio de Janeiro, BrazilTaking people
  • Rio De Janeiro, Rio De Janeiro Investigative Site 21016Rio de Janeiro, BrazilTaking people
  • SalvadorSalvador, BrazilTaking people
  • Santo AndréSanto André, BrazilNot yet recruiting
  • São CarlosSão Carlos, BrazilTaking people
  • São JoséSão José, BrazilTaking people
  • São José Dos Campos, Sao Paulo Investigative Site 21012São José dos Campos, BrazilTaking people
  • São José dos Campos, São Paulo Investigative Site 21081São José dos Campos, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • São PauloSão Paulo, BrazilTaking people
  • TeresinaTeresina, BrazilTaking people
  • Vila VelhaVila Velha, BrazilTaking people
  • VotuporangaVotuporanga, BrazilTaking people

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  4. What happens if I want to stop?
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Trial details

Who runs it
Colorado Prevention Center
Trial code
NCT06008197
Record updated
10 September 2026
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.

ClinicalTrials.gov NCT06008197