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Recruiting Phase 3 NCT06008197

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Phase 3 – large-scale trial before approval
Conditions: Heart Failure Acute Heart Failure

Sponsor: Colorado Prevention Center

trial.available_in: БГ
Overview
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.
Description
This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.
Who can participate
Inclusion Criteria: * 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 Criteria: * Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA) * Documented prior history of severe hyperkalemia in the setting of MRA use * Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m² or potassium \>5.0 mmol/L at screening * 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 * Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers * Known hypersensitivity to the IP (active substance or excipients)
Locations 18
Argentina (1)
Córdoba, Córdoba Investigative Site 20014
Córdoba , Córdoba Province
Australia (1)
Melbourne, VIC Investigative Site 50005
Melbourne , Victoria
Brazil (1)
Fortaleza, Ceará Investigative Site 21055
Fortaleza , Ceará I
ACTIVE_NOT_RECRUITING
Canada (1)
Edmonton, AB Investigative Site 11018
Edmonton , Alberta
Croatia (1)
Zagreb, Grad Zagreb Investigative Site 30005
Zagreb , Croatia
Czech Republic (1)
Chlumec nad Cidlinou, Czech Republic Investigative Site 31005
Chlumec nad Cidlinou , Czech Republic
Germany (1)
Berlin, Berlin Investigative Site 32001
Berlin , State of Berlin
Greece (1)
Athens, Investigative Site 33007
Athens , Greece
India (1)
Ahmedabad, Gujarat Investigative Site 51006
Ahmedabad , Gujarat
Italy (1)
Varese, Varese Investigative Site 35004
Varese , Varese
Lithuania (1)
Alytus, Lithuania Investigative Site 36005
Alytus , Lithuania
Malaysia (1)
Alor Setar, Kedah Investigative Site 52006
Alor Star , Kedah
Mexico (1)
CULIACÁN, Flores Investigative Site 23002
Culiacán , Flores
NOT_YET_RECRUITING
Peru (1)
Lima, Lima Investigative Site 24011
Lima , Lima Province
South Korea (1)
Seodaemun-gu, Seoul Investigative Site 53001
Seoul , Seoul
Spain (1)
Santiago De Compostela, Galicia Investigative Site 38008
Santiago de Compostela , Galicia
Taiwan (1)
Taipei, Taiwan Investigative Site 55008
Taipei , Taiwan
United States (1)
Glendale, AZ Investigative Site 10096
Glendale , Arizona
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.01.2024
Completion date
01.12.2027
Registry ID
NCT06008197
Source
anzctr
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