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Could a common diabetes drug save heart failure patients?

NCT ID NCT05392764

Disease control Sponsor: Juntendo University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether empagliflozin, a drug already used for diabetes, can help people hospitalized with acute heart failure. About 444 adults will receive either the drug or a placebo to see if it reduces deaths, hospital readmissions, and other serious events within 90 days. The goal is to find a safe, early treatment that improves outcomes for high-risk patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 444 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients who meet the below inclusion criteria will be randomized within 12 h after presentation to the hospital 1. Age of ≥20\* 2. Hospitalized with a diagnosis of acute heart failure, requiring intravenous loop diuretic therapy, and with all of the following characteristics: i. Dyspnoea at rest or induced by slight exertion ii. At least two of the following findings: jugular venous distention, pulmonary rales, lower leg edema, and pulmonary congestion on chest X-ray iii. If the patient has a sinus rhythm at the time of admission, BNP ≥350 pg/mL or NT-proBNP ≥1400 pg/mL; if the patient has atrial fibrillation at the time of admission, BNP ≥500 pg/mL or NT-proBNP ≥2000 pg/mL. For patients taking an angiotensin receptor neprilysin inhibitor, only the reference value for NT-proBNP will be applicable. 3. At least one of the following characteristics: i. eGFR \<60 mL/min/1.73m2, as calculated using the CKD Epidemiology Collaboration for JapaneseModification of Diet in Renal Disease formula ii. Already taking ≥40 mg of oral furosemide during the period before hospitalization. For patients on loop diuretics other than furosemide, the following conversion should be used: oral furosemide 20 mg = oral azosemide 30 mg = oral torasemide 5 mg. iii. Urine output of \<300 mL during the 2 h following an appropriate dose of intravenous furosemide administered after hospitalization. An appropriate dose of intravenous furosemide is 20 mg for patients who have not been taking furosemide regularly before hospitalization and is the same as, or greater than, the daily oral dose for patients who have been taking furosemide regularly before hospitalization. 4. Provided written consent to participate in the study \*If the patient is 90 years of age or older and cognitive decline is considered necessary, Mini-Cog should be used to confirm that its score is not less than 3. Exclusion Criteria: 1. eGFR \<20 mL/min/1.73m2 at the time of admission 2. Already taking an SGLT2i within 3 months prior to hospitalization 3. Type 1 diabetes mellitus 4. Systolic blood pressure \<90 mmHg 5. Expected to newly require treatment with thiazide, tolvaptan, or carperitide within 48 hours of study drug administration 6. Main cause of acute heart failure hospitalization is not fluid retention (e.g., persistent ventricular tachycardia, persistent atrial fibrillation/atrial flutter with a ventricular response rate of ≥130 bpm, persistent bradycardia with a ventricular response rate of \<45 bpm, an infection, severe anemia, and an acute exacerbation of COPD) 7. Acute coronary syndrome, pulmonary thromboembolism, or a cerebrovascular accident is the main cause of the present hospitalization. 8. At risk of ketoacidosis or hyperosmolar hyperglycaemia 9. On dialysis, including peritoneal dialysis, or the initiation of dialysis during hospitalization is planned 10. Pregnant or lactating women 11. Underwent the following therapeutic interventions within 30 days: 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, cardiac resynchronization therapy defibrillator, or implantable ventricular-assist device 12. A diagnosis of acute coronary syndrome, cerebral infarction, or transient ischemic attack made within 90 days 13. Ventricular tachycardia with syncope within 90 days 14. Heart transplant recipient or listed for heart transplantation and expected to undergo transplantation during the present treatment; implanted with an implantable ventricular-assist device or expected to require an implantable ventricular-assist device during the present treatment; or expected to switch to palliative care 15. Intubated at the time of screening or expected to require intubation within within 48 hours of study drug administration 16. Severe valvular heart disease expected to be treated with thoracostomy or catheterization (a reason to exclude secondary mitral or tricuspid regurgitation due to reduced cardiac function does not exist, except for the absence of a plan to perform cardiac surgery or therapeutic catheterization) 17. A diagnosis of secondary cardiomyopathy such as amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry disease, and muscular dystrophy. Heart failure due to takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complex congenital heart disease (as determined by the investigator), or pericardial constriction. 18. A diagnosis of peripartum cardiomyopathy made within 6 months 19. Active myocarditis 20. Presence of uncontrolled thyroid disease 21. Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae) 22. Symptomatic bradycardia or complete atrioventricular block, being treated with a temporary pacemaker implantation at the time of admission, or expected to require a temporary pacemaker implantation in the future. Patients who have already been treated with a permanent pacemaker implantation do not meet the exclusion criteria. 23. Serious liver disorder (an increase in AST, ALT, or ALP level ≥3 times the upper limit of normal) or cirrhosis with varices or other findings suggestive of portal hypertension 24. Alcohol use disorder of at least mild severity according to the DSM-V 25. A diagnosis of active malignancy or suspected active malignancy made within 2 years 26. Coexisting diseases other than heart failure with an expected survival prognosis of ≤1 year 27. Participation in a clinical study of another drug 30 days before hospitalization 28. Patients considered to require fasting at screening. 29. Other conditions likely to interfere with the patient's safety or compliance with the protocol 30. Other patients who are considered unsuitable by the principal investigator or other investigators

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    64 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aichi Medical University Hospital

    RECRUITING

    Nagakute, Aichi-ken, Japan

  • Anjo Kosei Hospital

    RECRUITING

    Anjo, Aichi-ken, Japan

  • Chikamori Hospital

    RECRUITING

    Kochi, Kochi, Japan

  • Fukuokaken Saiseikai Futsukaichi Hospital

    RECRUITING

    Chikushino-shi, Fukuoka, Japan

  • Funabashi Municipal Medical Center

    RECRUITING

    Funabashi, Chiba, Japan

  • Gifu University Graduate school of Medicine

    RECRUITING

    Gifu, Japan

  • Gunma University Hospital

    RECRUITING

    Maebashi, Gunma, Japan

  • Hanwa Memorial Hospital

    RECRUITING

    Osaka, Japan

  • Hirosaki University Hospital

    RECRUITING

    Hirosaki, Aomori, Japan

  • Hiroshima City Hospital

    RECRUITING

    Hiroshima, Hiroshima, Japan

  • Hyogo Prefectural Awaji Medical Center

    ACTIVE_NOT_RECRUITING

    Sumoto, Awaji, Japan

  • Iizuka Hospital

    RECRUITING

    Fukuoka, Japan

  • International Goodwill Hospital

    RECRUITING

    Kanagawa, Japan

  • International University of Health and Welfare Mita Hospital

    RECRUITING

    Minato, Tokyo, Japan

  • Iwate Prefectural Cyuou Hospital

    RECRUITING

    Morioka, Iwate, Japan

  • Japanese Red Cross Fukuoka Hospital

    RECRUITING

    Fukuoka, Fukuoka, Japan

  • Juntendo University Hospital

    RECRUITING

    Tokyo, Japan

  • Juntendo University Nerima Hospital

    RECRUITING

    Tokyo, Tokyo, Japan

  • Juntendo University Shizuoka Hospital

    RECRUITING

    Izunokuni, Shizuoka, Japan

  • Juntendo University Urayasu Hospital

    RECRUITING

    Urayasu, Chiba, Japan

  • Kameda Medical Center

    RECRUITING

    Kamogawa, Chiba, Japan

  • Kasukabe Chuo General Hospital

    RECRUITING

    Kasukabe, Saitama, Japan

  • Kawaguchi Cardiovascular and Respiratory Hospital

    RECRUITING

    Kawaguchi, Saitama, Japan

  • Kindai University Hospital

    RECRUITING

    Sayama, Osaka, Japan

  • Kitano Hospital

    RECRUITING

    Osaka, Osaka, Japan

  • Kitasato University Hospital

    RECRUITING

    Kanagawa, Japan

  • Kochi Medical School Hospital

    RECRUITING

    Nankoku, Kochi, Japan

  • Kurume University Hospital

    RECRUITING

    Kurume, Fukuoka, Japan

  • Kushiro-sanjikai Hospital

    RECRUITING

    Kushiro, Hokkaido, Japan

  • Medical Corporation Sapporo Heart Center

    RECRUITING

    Sapporo, Hokkaido, Japan

  • Mitsui Memorial Hospital

    RECRUITING

    Chiyoda City, Tokyo, Japan

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aichi-ken, Japan

  • Nakagami Hospital

    ACTIVE_NOT_RECRUITING

    Okinawa, Okinawa, Japan

  • Nara Medical University Hospital

    RECRUITING

    Kashihara, Nara, Japan

  • Nara Prefecture General Medical Center

    RECRUITING

    Nara, Nara, Japan

  • National Cerebral and Cardiovascular Center Hospital

    RECRUITING

    Suita, Osaka, Japan

  • National Disaster Medical Center

    RECRUITING

    Tachikawa, Tokyo, Japan

  • Nayoro City General Hospital Contact:

    RECRUITING

    Hokkaido, Japan

  • Nihon University Itabashi Hospital

    RECRUITING

    Tokyo, Japan

  • Nippon Medical School Hospital

    RECRUITING

    Tokyo, Japan

  • Nishiarai Hospital

    ACTIVE_NOT_RECRUITING

    Adachi City, Tokyo, Japan

  • Ogaki Municipal Hospital

    RECRUITING

    Ōgaki, Gifu, Japan

  • Osaka General Medical Center

    RECRUITING

    Osaka, Osaka, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    RECRUITING

    Osaka, Japan

  • SHOWA Medical University Fujigaoka Hospital

    RECRUITING

    Kanagawa, Japan

  • Saiseikai Utsunomiya Hospital

    RECRUITING

    Utsunomiya, Tochigi, Japan

  • Saitama Citizens Medical Center

    ACTIVE_NOT_RECRUITING

    Saitama, Saitama, Japan

  • Saitama Medical Center

    RECRUITING

    Kawagoe, Saitama, Japan

  • Sakakibara Heart Institute

    RECRUITING

    Fuchū, Tokyo, Japan

  • Sakakibara Heart Institute of Okayama

    RECRUITING

    Okayama, Okayama-ken, Japan

  • Sapporo Higashi Tokushukai Hospital

    RECRUITING

    Sapporo, Hokkaido, Japan

  • Seirei Mikatahara General Hospital

    RECRUITING

    Hamamatsu, Shizuoka, Japan

  • Shonan Kamakura General Hospital

    RECRUITING

    Kamakura, Kanagawa, Japan

  • Soka City Hospital

    RECRUITING

    Sōka, Saitama, Japan

  • St. Luke's International Hospital

    RECRUITING

    Tokyo, Japan

  • St.Marianna University School of Medicine Hospital

    RECRUITING

    Kawasaki, Kanagawa, Japan

  • The Jikei University Hospital

    RECRUITING

    Tokyo, Japan

  • Tokai University Hospital

    RECRUITING

    Isehara, Kanagawa, Japan

  • Tokushima University Hospital

    RECRUITING

    Tokushima, Tokushima, Japan

  • Tokyo General Hospital

    RECRUITING

    Tokyo, Japan

  • Tokyo Medical University

    RECRUITING

    Tokyo, Japan

  • Tokyo Medical University Hachioji Medical Center

    RECRUITING

    Hachiōji, Tokyo, Japan

  • Tokyo Metropolitan Bokutoh Hospital

    ACTIVE_NOT_RECRUITING

    Tokyo, Tokyo, Japan

  • Tokyo Saiseikai Central Hospital

    RECRUITING

    Tokyo, Japan

  • Tokyo Women's Medical University Hospital

    RECRUITING

    Shinjuku, Tokyo, Japan

  • Toranomon Hospital

    RECRUITING

    Minato, Tokyo, Japan

  • Tsuchiura Kyodo General Hospital

    RECRUITING

    Tsuchiura, Ibaraki, Japan

  • Urasoe General Hospital

    RECRUITING

    Urasoe, Okinawa, Japan

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, Yokohama, Japan

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