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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Acute Heart Failure

In brief

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.

Key facts

Study ID: NCT07397650
Run by: Juntendo University
People needed: 550
Starts: 2026-05-11
Expected to finish: 2028-09-30
Last updated by the study team: 2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m2 by CKD-EPI Creatinine Equation (2021) at screening
Serum/plasma potassium >5.0 mmol/L at screening
Patients who cannot receive oral treatment
Use of eplerenone, spironolactone, esaxerenone or potassium-sparing diuretic within 30 days before randomization
Known hypersensitivity to the study intervention (active substance or excipients)
Systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers within 7 days before randomization or is expected to be used during the study period (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin).
Participants who require treatment with more than one ACEI, ARB or angiotensin-receptor neprilysin inhibitor (ARNI) simultaneously
Acute heart failure in which other diseases are the main cause of symptoms and signs (chronic obstructive pulmonary disease, anemia, etc.)
Patients who are on dialysis including peritoneal dialysis or in whom the initiation of dialysis during the study period
Pregnant or lactating female
Acute coronary syndrome, pulmonary thromboembolism, stroke, or transient ischemic attack within 90 days before randomization.
Have undergone the following therapeutic intervention within 30 days before randomization: cardiovascular surgery (e.g., coronary artery bypass grafting, surgery for valvular heart disease, transcatheter aortic valve implantation, percutaneous coronary intervention, percutaneous edge-to-edge mitral valve repair, and other types of surgery at the investigator's discretion) and implantation of an implantable defibrillator, or a cardiac resynchronization therapy defibrillator.
Heart transplant recipients or patients listed for heart transplantation who are expected to undergo transplantation during the study, patients implanted with an implantable ventricular-assist device, patients expected to require an implantable ventricular-assist device during the study, and patients expected to switch to palliative care during the study.
Coronary or valvular heart disease likely to require surgical or percutaneous intervention within the study period (there is no reason to exclude secondary mitral or tricuspid regurgitation due to reduced cardiac function, except for the absence of a plan to perform cardiac surgery or therapeutic catheterization)
Secondary cardiomyopathy such as amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry's disease, chemotherapy induced cardiomyopathy, and muscular dystrophy. Heart failure due to takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complex congenital heart disease (as determined by the investigator), pericardial constriction, right heart failure in absence of left-sided structural disease
Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae and infective endocarditis)
Peripartum cardiomyopathy diagnosed within 6 months before randomization.
Active myocarditis at randomization.
Patients with symptomatic bradycardia or complete atrioventricular block who are being treated with temporary pacemaker implantation at the time of admission, or who are expected to require temporary or permanent pacemaker implantation in the future. Patients who have already been treated with permanent pacemaker implantation do not meet the exclusion criteria
Presence of uncontrolled thyroid disease
Addison's disease
Hepatic insufficiency classified as Child-Pugh C
Patients with excessive alcohol intake (15+ drinks/week for men, 8+ drinks/week for women)
Any other condition or therapy, which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months)
Patients with dementia. If a sub-investigator determines that confirmation of cognitive impairment is necessary, it must be verified that the Mini-Cog score is not less than 4.

Where it is running

Juntendo University Hospital — Tokyo, Japan (enrolling)
Gunma University Hospital — Maebashi, Gunma, Japan (enrolling)
NHO Takasaki General Medical Center — Takasaki, Gunma, Japan (enrolling)
Hokkaido Cardiovascular Hospital — Sapporo, Hokkaido, Japan (enrolling)
Kindai University Hospital — Sakai, Osaka, Japan (enrolling)
The University of Osaka Hospital — Suita, Osaka, Japan (enrolling)
Chutoen General Medical Center — Kakegawa, Shizuoka, Japan (enrolling)
Osaka General Medical Center — Osaka, Japan (enrolling)
Chita Peninsula General Medical Center — Handa, Aichi-ken, Japan (enrolling)
Nagoya University Hospital — Nagoya, Aichi-ken, Japan (enrolling)
Toyota Kosei Hospital — Toyota, Aichi-ken, Japan (enrolling)
Ehime University Hospital — Tōon, Ehime, Japan (enrolling)
Iizuka Hospital — Iizuka, Fukuoka, Japan (enrolling)
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital — Nagoya, Aichi-ken, Japan
Saitama Medical Center — Kawagoe, Saitama, Japan
National Center for Geriatrics and Gerontology — Ōbu, Aichi-ken, Japan
National Cerebral and Cardiovascular Center — Suita, Osaka, Japan
Juntendo University Shizuoka Hospital — Izunokuni, Shizuoka, Japan
Japanese Red Cross Fukuoka Hospital — Fukuoka, Fukuoka, Japan
Kitasato University Hospital — Sagamihara, Kanagawa, Japan
Gunma Prefectural Cardiovascular Center — Maebashi, Gunma, Japan

Full record on ClinicalTrials.gov

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