Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure (FACILITATE-HF)

August 5, 2026 updated by: Juntendo University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Osaka, Japan
        • Recruiting
        • Osaka General Medical Center
        • Contact:
          • Mitsutoshi Asai
      • Tokyo, Japan
        • Recruiting
        • Juntendo University Hospital
        • Contact:
          • Yuya Matsue
    • Aichi-ken
      • Handa, Aichi-ken, Japan
        • Recruiting
        • Chita Peninsula General Medical Center
        • Contact:
          • Susumu Suzuki
      • Nagoya, Aichi-ken, Japan
        • Recruiting
        • Nagoya University Hospital
        • Contact:
          • Toru Kondo
      • Nagoya, Aichi-ken, Japan
        • Not yet recruiting
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
        • Contact:
          • Hideo Oishi
      • Toyota, Aichi-ken, Japan
        • Recruiting
        • Toyota Kosei Hospital
        • Contact:
          • Tomoaki Haga
      • Ōbu, Aichi-ken, Japan
        • Not yet recruiting
        • National Center for Geriatrics and Gerontology
        • Contact:
          • Atsuya Shimizu
    • Ehime
      • Tōon, Ehime, Japan
        • Recruiting
        • Ehime University Hospital
        • Contact:
          • Osamu Yamaguchi
    • Fukuoka
      • Fukuoka, Fukuoka, Japan
        • Not yet recruiting
        • Japanese Red Cross Fukuoka Hospital
        • Contact:
          • Yasuhiro Oga
      • Iizuka, Fukuoka, Japan
        • Recruiting
        • Iizuka Hospital
        • Contact:
          • Ryuichi Matsukawa
    • Gunma
      • Maebashi, Gunma, Japan
        • Recruiting
        • Gunma University Hospital
        • Contact:
          • Masaru Obokata
      • Maebashi, Gunma, Japan
        • Not yet recruiting
        • Gunma Prefectural Cardiovascular Center
        • Contact:
          • Norimichi Koitabashi
      • Takasaki, Gunma, Japan
        • Recruiting
        • NHO Takasaki General Medical Center
        • Contact:
          • Nobuaki Fukuda
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • Hokkaido Cardiovascular Hospital
        • Contact:
          • Kazunori Omote
    • Kanagawa
      • Sagamihara, Kanagawa, Japan
        • Not yet recruiting
        • Kitasato University Hospital
        • Contact:
          • Takeru Nabeta
    • Osaka
      • Sakai, Osaka, Japan
        • Recruiting
        • Kindai University Hospital
        • Contact:
          • Koichiro Matsumura
      • Suita, Osaka, Japan
        • Recruiting
        • The University of Osaka Hospital
        • Contact:
          • Yohei Sotomi
      • Suita, Osaka, Japan
        • Not yet recruiting
        • National Cerebral and Cardiovascular Center
        • Contact:
          • Takeshi Kitai
    • Saitama
      • Kawagoe, Saitama, Japan
        • Not yet recruiting
        • Saitama Medical Center
        • Contact:
          • Kentaro Jujo
    • Shizuoka
      • Izunokuni, Shizuoka, Japan
        • Not yet recruiting
        • Juntendo University Shizuoka Hospital
        • Contact:
          • Manabu Ogita
      • Kakegawa, Shizuoka, Japan
        • Recruiting
        • Chutoen General Medical Center
        • Contact:
          • Shuji Morikawa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Patients eligible for inclusion in this study meet all of the following criteria:
Inclusion Criteria:

  1. Patients ≥18 years of age, male or female
  2. Current hospitalization with AHF requiring intravenous loop diuretics or vasodilators during the index admission
  3. 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
    (i) symptom
    dyspnoea, decreased exercise tolerance, or fatigue
    (ii) physical examination
    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

  4. Patients who are not hemodynamically unstable as defined by meeting the following criteria

    1. Systolic blood pressure ≥100 mmHg and no symptoms of hypotension within 6 hours prior to randomization
    2. No increase in intravenous diuretic dose or intravenous vasodilators within 6 hours prior to randomization with worsening HF symptom
    3. 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
  5. 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)
  6. Most recent LVEF ≥40% within the past 1 year
  7. Randomization within 24 hours after admission, and drug administration within 36 hours after admission
  8. 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
  9. Signed informed consent must be obtained prior to participation in the study

Exclusion Criteria:

  1. Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m2 by CKD-EPI Creatinine Equation (2021) at screening
  2. Serum/plasma potassium >5.0 mmol/L at screening
  3. Patients who cannot receive oral treatment
  4. Use of eplerenone, spironolactone, esaxerenone or potassium-sparing diuretic within 30 days before randomization
  5. Known hypersensitivity to the study intervention (active substance or excipients)
  6. 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).
  7. Participants who require treatment with more than one ACEI, ARB or angiotensin-receptor neprilysin inhibitor (ARNI) simultaneously
  8. Acute heart failure in which other diseases are the main cause of symptoms and signs (chronic obstructive pulmonary disease, anemia, etc.)
  9. Patients who are on dialysis including peritoneal dialysis or in whom the initiation of dialysis during the study period
  10. Pregnant or lactating female
  11. Acute coronary syndrome, pulmonary thromboembolism, stroke, or transient ischemic attack within 90 days before randomization.
  12. 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.
  13. 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.
  14. 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)
  15. 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
  16. Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae and infective endocarditis)
  17. Peripartum cardiomyopathy diagnosed within 6 months before randomization.
  18. Active myocarditis at randomization.
  19. 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
  20. Presence of uncontrolled thyroid disease
  21. Addison's disease
  22. Hepatic insufficiency classified as Child-Pugh C
  23. Patients with excessive alcohol intake (15+ drinks/week for men, 8+ drinks/week for women)
  24. 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)
  25. 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.
  26. Participation in another interventional clinical study (e.g. phase 1 to 3 clinical studies) or treatment with another investigational medicinal product within 30 days prior to randomization.Other conditions likely to interfere with the patient's safety or compliance with the protocol
  27. Patients deemed unsuitable by the principal investigator or sub investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Finerenone
Patients will be randomized 1:1 to either finerenone or placebo.
Drug: Finerenone 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.
Placebo Comparator: Placebo
Placebo tablets matching finerenone are administered orally
Drug: Finerenone Placebo
Placebo tablets matching finerenone are administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A hierarchical composite endpoint of death and worsening heart failure
Time Frame: Up to 12 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: Up to 12 weeks
Up to 12 weeks
Cardiovascular death
Time Frame: Up to 12 weeks
Up to 12 weeks
Worsening HF during hospitalization
Time Frame: During hospitalization
During hospitalization
HF rehospitalization
Time Frame: Up to 12 weeks
Up to 12 weeks
Worsening HF after discharge requiring IV diuretic or sustained intensification of oral therapy
Time Frame: Up to 12 weeks
Up to 12 weeks
NT-proBNP change from baseline to 12 weeks
Time Frame: Up to 12 weeks
Up to 12 weeks
Urine output from randomization to 48 hours
Time Frame: Up to 48 hours
Up to 48 hours
Symptomatic atrial fibrillation up to discharge and up to 12 weeks
Time Frame: Up to 12 weeks
Up to 12 weeks
Kansas City Cardiomyopathy Questionnaire - Total Symptom Score from baseline to 12 weeks
Time Frame: Up to 12 weeks
Kansas City Cardiomyopathy Questionnaire - Total Symptom Score from baseline to 12 weeks. The scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations.
Up to 12 weeks
Change in patient dyspnea in the supine position assessed by a visual analogue scale from randomization to discharge and to 12 weeks
Time Frame: Up to 12 weeks
Change in patient dyspnea in the supine position assessed by a visual analogue scale from randomization to discharge and to 12 weeks. The scores range from 0 to 100, with 100 being the best possible score.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Juntendo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuya Matsue, MD, Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • jRCTs031250369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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