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)

CPC Clinical Research0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•Males and females age >=18 years
•Current hospitalization or recently discharged 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) >=1000 pg/mL or B-type natriuretic peptide (BNP) >=250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP >=2000 pg/mL or BNP >=500 pg/mL for patients with AF

•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 serum/plasma potassium >5.0 mmol/L at screening
•Acute myocardial infarction, 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

发起方