RecruitingPhase 4NCT07397650

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

Sponsor

Juntendo University

Enrollment

550 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Heart Failure

Summary

FACILITATE-HF is a multicenter, randomized, double-blind, placebo-controlled trial designed to determine whether initiation of finerenone during the early phase of hospitalization has beneficial effects in patients with AHF who have left ventricular ejection fraction 40% or more.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether starting a medication called finerenone — a drug that blocks a hormone involved in heart stress and inflammation — early during a hospital stay for acute heart failure leads to better outcomes compared to starting it after discharge. Finerenone is already used in heart failure, but the timing of when to start it is being investigated here. **You may be eligible if...** - You are 18 or older - You are currently hospitalized for worsening heart failure and receiving IV diuretics (water pills) or vasodilators (drugs to open blood vessels) - You show new or worsening heart failure symptoms such as shortness of breath, swelling, or fluid buildup **You may NOT be eligible if...** - Your kidneys are functioning at a very low level - Your blood potassium level is too high - You have low blood pressure or are in cardiogenic shock - You are pregnant or breastfeeding - You are already taking finerenone or have a known contraindication to it Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFinerenone Oral Tablet

For participants with an eGFR ≤60 mL/min/1.73 m\^2: Starting dose is 10 mg OD and maximum dose 20 mg OD. For participants with an eGFR \>60 mL/min/1.73 m\^2: Starting dose is 20 mg OD and maximum dose 40 mg OD.

DRUGFinerenone Placebo

Placebo tablets matching finerenone are administered orally

Locations(21)

Chita Peninsula General Medical Center

Handa, Aichi-ken, Japan

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

Toyota Kosei Hospital

Toyota, Aichi-ken, Japan

Ehime University Hospital

Tōon, Ehime, Japan

Japanese Red Cross Fukuoka Hospital

Fukuoka, Fukuoka, Japan

Iizuka Hospital

Iizuka, Fukuoka, Japan

Gunma Prefectural Cardiovascular Center

Maebashi, Gunma, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

NHO Takasaki General Medical Center

Takasaki, Gunma, Japan

Hokkaido Cardiovascular Hospital

Sapporo, Hokkaido, Japan

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Kindai University Hospital

Sakai, Osaka, Japan

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Saitama Medical Center

Kawagoe, Saitama, Japan

Juntendo University Shizuoka Hospital

Izunokuni, Shizuoka, Japan

Chutoen General Medical Center

Kakegawa, Shizuoka, Japan

Osaka General Medical Center

Osaka, Japan

Juntendo University Hospital

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07397650

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