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Набира участници Фаза 3 NCT06008197

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Heart Failure Acute Heart Failure

Спонсор: Colorado Prevention Center

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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)
Места на провеждане 18
Argentina (1)
Córdoba, Córdoba Investigative Site 20014
Córdoba , Córdoba Province
Австралия (1)
Melbourne, VIC Investigative Site 50005
Melbourne , Victoria
Бразилия (1)
Fortaleza, Ceará Investigative Site 21055
Fortaleza , Ceará I
ACTIVE_NOT_RECRUITING
Канада (1)
Edmonton, AB Investigative Site 11018
Edmonton , Alberta
Хърватия (1)
Zagreb, Grad Zagreb Investigative Site 30005
Zagreb , Croatia
Чехия (1)
Chlumec nad Cidlinou, Czech Republic Investigative Site 31005
Chlumec nad Cidlinou , Czech Republic
Германия (1)
Berlin, Berlin Investigative Site 32001
Berlin , State of Berlin
Гърция (1)
Athens, Investigative Site 33007
Athens , Greece
Индия (1)
Ahmedabad, Gujarat Investigative Site 51006
Ahmedabad , Gujarat
Италия (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
Южна Корея (1)
Seodaemun-gu, Seoul Investigative Site 53001
Seoul , Seoul
Испания (1)
Santiago De Compostela, Galicia Investigative Site 38008
Santiago de Compostela , Galicia
Taiwan (1)
Taipei, Taiwan Investigative Site 55008
Taipei , Taiwan
САЩ (1)
Glendale, AZ Investigative Site 10096
Glendale , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
17.01.2024
Крайна дата
01.12.2027
Регистрационен номер
NCT06008197
Източник
anzctr
Запитване за медицински туризъм

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