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Phase 4
Age: 18Years +
All Genders
ID07397650

Early Treatment With Finerenone for Adults Hospitalized With Acute Heart Failure and Reduced Heart Function

Led by Juntendo University · Updated on 2026-08-10

550

Participants Needed

21

Research Sites

43 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of early treatment with finerenone in patients hospitalized with acute heart failure AHF who have a left ventricular ejection fraction of 40% or more. This phase 4, randomized, double-blind, placebo-controlled trial aims to determine whether starting finerenone during the early phase of hospitalization improves outcomes compared to placebo. Participants are randomly assigned to receive either finerenone or a matching placebo orally. The dosing of finerenone depends on kidney function for those with an eGFR of 60 mLmin1.73 m or less, dosing starts at 10 mg once daily up to 20 mg for those with an eGFR above 60 mLmin1.73 m, dosing starts at 20 mg once daily up to 40 mg. The study treatment is initiated within 36 hours of hospital admission, with randomization occurring within 24 hours. During the study, participants are monitored up to 12 weeks for a composite outcome of death and worsening heart failure, with assessments including heart failure rehospitalization, changes in heart failure symptoms, and biomarker levels such as NT-proBNP. Additional evaluations cover urine output, dyspnea, atrial fibrillation symptoms, and quality of life via questionnaires. Safety and efficacy are closely observed throughout the treatment and follow-up period.

CONDITIONS

Brief Title

Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure

Research Team

Y

Yuya Matsue, MD

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