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

NCT07397650 | Recruiting Phase 4 DMC

• 1 other identifier: jRCTs031250369
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• A hierarchical composite endpoint of death and worsening heart failure

  A hierarchical composite endpoint consisting of death, worsening HF during hospitalization, HF rehospitalization, worsening HF after discharge requiring IV diuretic or sustained intensification of oral therapy, and change in N-terminal pro-B-type natriuretic peptide levels at 12 weeks as assessed using a win ratio

  Up to 12 weeks

Secondary Outcomes (10)

• All-cause death

  Up to 12 weeks

• Cardiovascular death

  Up to 12 weeks

• Worsening HF during hospitalization

  During hospitalization

• HF rehospitalization

  Up to 12 weeks

• Worsening HF after discharge requiring IV diuretic or sustained intensification of oral therapy

  Up to 12 weeks

Study Arms (2)

Finerenone

EXPERIMENTAL

Patients will be randomized 1:1 to either finerenone or placebo.

Drug: Finerenone Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo tablets matching finerenone are administered orally

Drug: Finerenone Placebo

Interventions

Finerenone Oral Tablet DRUG

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.

Finerenone

Finerenone Placebo DRUG

Placebo tablets matching finerenone are administered orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years of age, male or female\<br\>
• Current hospitalization with AHF requiring intravenous loop diuretics or vasodilators during the index admission\<br\>
• Patients have to have at least one of new or worsening symptoms due to HF and one of new or worsening physical examination findings due to HF \<br\> (i) symptom\<br\> dyspnoea, decreased exercise tolerance, or fatigue\<br\> (ii) physical examination\<br\> peripheral edema, increasing abdominal distention or ascites, pulmonary rales/crackles/crepitations, increased jugular venous pressure and/or hepatojugular reflux, S3 gallop, clinically significant or rapid weight gain\<br\>
• Patients who are not hemodynamically unstable as defined by meeting the following criteria\<br\>
• Systolic blood pressure ≥100 mmHg and no symptoms of hypotension within 6 hours prior to randomization\<br\>
• No increase in intravenous diuretic dose or intravenous vasodilators within 6 hours prior to randomization with worsening HF symptom\<br\>
• Without cardiogenic shock, no use of inotropes or vasopressors, no use of mechanical circulatory support, not requiring intubation after admission, and not expected to require inotropes, vasopressors, mechanical circulatory support or intubation during the index hospitalization\<br\>
• NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL (For patients treated with ARNI in the previous 4 weeks prior to randomization, only NT-proBNP values should be used)\<br\>
• Most recent LVEF ≥40% within the past 1 year \<br\>
• Randomization within 24 hours after admission, and drug administration within 36 hours after admission \<br\>
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\<br\>
• Signed informed consent must be obtained prior to participation in the study\<br\>

You may not qualify if:

• Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m2 by CKD-EPI Creatinine Equation (2021) at screening\<br\>
• Serum/plasma potassium \>5.0 mmol/L at screening\<br\>
• Patients who cannot receive oral treatment\<br\>
• Use of eplerenone, spironolactone, esaxerenone or potassium-sparing diuretic within 30 days before randomization \<br\>
• Known hypersensitivity to the study intervention (active substance or excipients)\<br\>
• 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).\<br\>
• Participants who require treatment with more than one ACEI, ARB or angiotensin-receptor neprilysin inhibitor (ARNI) simultaneously\<br\>
• Acute heart failure in which other diseases are the main cause of symptoms and signs (chronic obstructive pulmonary disease, anemia, etc.)\<br\>
• Patients who are on dialysis including peritoneal dialysis or in whom the initiation of dialysis during the study period\<br\>
• Pregnant or lactating female\<br\>
• Acute coronary syndrome, pulmonary thromboembolism, stroke, or transient ischemic attack within 90 days before randomization.\<br\>
• 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.\<br\>
• 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.\<br\>
• 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)\<br\>
• 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\<br\>

Sponsors & Collaborators

• Juntendo University: lead

Study Sites (21)

Chita Peninsula General Medical Center

Handa, Aichi-ken, Japan

RECRUITING

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

NOT YET RECRUITING

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

RECRUITING

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

NOT YET RECRUITING

Toyota Kosei Hospital

Toyota, Aichi-ken, Japan

RECRUITING

Ehime University Hospital

Tōon, Ehime, Japan

RECRUITING

Japanese Red Cross Fukuoka Hospital

Fukuoka, Fukuoka, Japan

NOT YET RECRUITING

Iizuka Hospital

Iizuka, Fukuoka, Japan

RECRUITING

Gunma Prefectural Cardiovascular Center

Maebashi, Gunma, Japan

NOT YET RECRUITING

Gunma University Hospital

Maebashi, Gunma, Japan

RECRUITING

NHO Takasaki General Medical Center

Takasaki, Gunma, Japan

RECRUITING

Hokkaido Cardiovascular Hospital

Sapporo, Hokkaido, Japan

RECRUITING

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

NOT YET RECRUITING

Kindai University Hospital

Sakai, Osaka, Japan

RECRUITING

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

NOT YET RECRUITING

The University of Osaka Hospital

Suita, Osaka, Japan

RECRUITING

Saitama Medical Center

Kawagoe, Saitama, Japan

NOT YET RECRUITING

Juntendo University Shizuoka Hospital

Izunokuni, Shizuoka, Japan

NOT YET RECRUITING

Chutoen General Medical Center

Kakegawa, Shizuoka, Japan

RECRUITING

Osaka General Medical Center

Osaka, Japan

RECRUITING

Juntendo University Hospital

Tokyo, Japan

RECRUITING

MeSH Terms

Interventions

finerenone

Study Officials

• Yuya Matsue, MD

  Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuya Matsue, MD

CONTACT

81-3-3813-3111; yuya8950@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

JP (21)