Acute Heart FailurePhase 4FACILITATE-HFNCT07397650
Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure
A Phase 4 study testing Finerenone Oral Tablet in people with Acute Heart Failure, run by Juntendo University at 21 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Finerenone Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 21 sitesJapan
- Study dates
- 11 May 2026to 30 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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>
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- 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>
- Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae and infective endocarditis)<br>
- Peripartum cardiomyopathy diagnosed within 6 months before randomization.<br>
- Active myocarditis at randomization.<br>
- 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<br>
- Presence of uncontrolled thyroid disease<br>
- Addison's disease<br>
- Hepatic insufficiency classified as Child-Pugh C <br>
- Patients with excessive alcohol intake (15+ drinks/week for men, 8+ drinks/week for women)<br>
- 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)<br>
- 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.<br>
- 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<br>
- Patients deemed unsuitable by the principal investigator or sub investigator
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Japan21 sites, 21 recruiting
- Not yet recruiting
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka
Yasuhiro Oga
- Recruiting
Chita Peninsula General Medical Center
Handa, Aichi-ken
Susumu Suzuki
- Recruiting
Iizuka Hospital
Iizuka, Fukuoka
Ryuichi Matsukawa
- Not yet recruiting
Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka
Manabu Ogita
- Recruiting
Chutoen General Medical Center
Kakegawa, Shizuoka
Shuji Morikawa
- Not yet recruiting
Saitama Medical Center
Kawagoe, Saitama
Kentaro Jujo
- Not yet recruiting
Gunma Prefectural Cardiovascular Center
Maebashi, Gunma
Norimichi Koitabashi
- Recruiting
Gunma University Hospital
Maebashi, Gunma
Masaru Obokata
- Not yet recruiting
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken
Hideo Oishi
- Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken
Toru Kondo
- Not yet recruiting
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken
Atsuya Shimizu
- Recruiting
Osaka General Medical Center
Osaka
Mitsutoshi Asai
- Not yet recruiting
Kitasato University Hospital
Sagamihara, Kanagawa
Takeru Nabeta
- Recruiting
Kindai University Hospital
Sakai, Osaka
Koichiro Matsumura
- Recruiting
Hokkaido Cardiovascular Hospital
Sapporo, Hokkaido
Kazunori Omote
- Not yet recruiting
National Cerebral and Cardiovascular Center
Suita, Osaka
Takeshi Kitai
- Recruiting
The University of Osaka Hospital
Suita, Osaka
Yohei Sotomi
- Recruiting
NHO Takasaki General Medical Center
Takasaki, Gunma
Nobuaki Fukuda
- Recruiting
Juntendo University Hospital
Tokyo
Yuya Matsue
- Recruiting
Ehime University Hospital
Tōon, Ehime
Osamu Yamaguchi
- Recruiting
Toyota Kosei Hospital
Toyota, Aichi-ken
Tomoaki Haga
About this study
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
- Being tested
- Finerenone Oral Tablet, Finerenone Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone Oral TabletDrug
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 PlaceboDrug
Placebo tablets matching finerenone are administered orally
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Patients will be randomized 1:1 to either finerenone or placebo. Receives: Drug: Finerenone Oral Tablet |
| Placebo | Placebo comparator | Placebo tablets matching finerenone are administered orally Receives: Drug: Finerenone Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 weeks
Secondary outcomes (10)
All-cause death
Measured: Up to 12 weeks
Cardiovascular death
Measured: Up to 12 weeks
Worsening HF during hospitalization
Measured: During hospitalization
HF rehospitalization
Measured: Up to 12 weeks
Worsening HF after discharge requiring IV diuretic or sustained intensification of oral therapy
Measured: Up to 12 weeks
NT-proBNP change from baseline to 12 weeks
Measured: Up to 12 weeks
Kansas City Cardiomyopathy Questionnaire - Total Symptom Score from baseline 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.
Measured: Up to 12 weeks
Urine output from randomization to 48 hours
Measured: Up to 48 hours
Change in patient dyspnea in the supine position assessed by a visual analogue scale from randomization to discharge and 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.
Measured: Up to 12 weeks
Symptomatic atrial fibrillation up to discharge and up to 12 weeks
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start11 May 2026
- Primary completionDec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juntendo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuya Matsue, MD, Principal investigator, Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397650
- Sponsor's protocol ID
- jRCTs031250369
- Acronym
- FACILITATE-HF
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07397650
- Acronym / sponsor ID
- FACILITATE-HF / jRCTs031250369
- Conditions
- Acute Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Juntendo UniversityUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: Finerenone Oral TabletPatients will be randomized 1:1 to either finerenone or placebo. |
| Placebo | Placebo comparator | Drug: Finerenone PlaceboPlacebo tablets matching finerenone are administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (27 listed)
- 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>
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone Oral TabletFor 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. | Drug | Finerenone |
| Finerenone PlaceboPlacebo tablets matching finerenone are administered orally | Drug | Placebo |
Primary outcome
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
10 secondary outcomes
All-cause death
Time frame: Up to 12 weeks
Cardiovascular death
Time frame: Up to 12 weeks
Worsening HF during hospitalization
Time frame: During hospitalization
HF rehospitalization
Time frame: Up to 12 weeks
Worsening HF after discharge requiring IV diuretic or sustained intensification of oral therapy
Time frame: Up to 12 weeks
NT-proBNP change from baseline to 12 weeks
Time frame: Up to 12 weeks
Kansas City Cardiomyopathy Questionnaire - Total Symptom Score from baseline to 12 weeks
Time frame: Up to 12 weeks
Urine output from randomization to 48 hours
Time frame: Up to 48 hours
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
Symptomatic atrial fibrillation up to discharge and up to 12 weeks
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuya Matsue, MD principal investigator
Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone Oral Tablet in people with Acute Heart Failure, run by Juntendo University at 21 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuya Matsue, MD (81-3-3813-3111, yuya8950@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A hierarchical composite endpoint of death and worsening heart failure (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.