SLCTR/2024/022Not yet recruitingPhase 3
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)
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- CPC Clinical Research
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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