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Acute Heart FailurePhase 3EMPA-AHFNCT05392764

Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure

A Phase 3 study testing Empagliflozin 10 MG in people with Acute Heart Failure, run by Juntendo University at 69 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for patients with acute heart failure (AHF) who are at a high risk of adverse events. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Acute Heart Failure
What is being tested?
Empagliflozin 10 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
444 participants
Where
69 sitesJapan
Study dates
10 Sep 2022to 31 Dec 2027
Phase
Phase 3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet the below inclusion criteria will be randomized within 12 h after presentation to the hospital
  • Age of ≥20*
  • Hospitalized with a diagnosis of acute heart failure, requiring intravenous loop diuretic therapy, and with all of the following characteristics:
  • 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.
  • At least one of the following characteristics:
  • 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.
  • 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.
  • 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.

Who cannot join

  • eGFR <20 mL/min/1.73m2 at the time of admission
  • Already taking an SGLT2i within 3 months prior to hospitalization
  • Type 1 diabetes mellitus
  • Systolic blood pressure <90 mmHg
  • Expected to newly require treatment with thiazide, tolvaptan, or carperitide within 48 hours of study drug administration
  • 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)
Show all 30Show fewer
  • Acute coronary syndrome, pulmonary thromboembolism, or a cerebrovascular accident is the main cause of the present hospitalization.
  • At risk of ketoacidosis or hyperosmolar hyperglycaemia
  • On dialysis, including peritoneal dialysis, or the initiation of dialysis during hospitalization is planned
  • Pregnant or lactating women
  • 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
  • A diagnosis of acute coronary syndrome, cerebral infarction, or transient ischemic attack made within 90 days
  • Ventricular tachycardia with syncope within 90 days
  • 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
  • Intubated at the time of screening or expected to require intubation within within 48 hours of study drug administration
  • 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)
  • 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.
  • A diagnosis of peripartum cardiomyopathy made within 6 months
  • Active myocarditis
  • Presence of uncontrolled thyroid disease
  • Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae)
  • 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.
  • 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
  • Alcohol use disorder of at least mild severity according to the DSM-V
  • A diagnosis of active malignancy or suspected active malignancy made within 2 years
  • Coexisting diseases other than heart failure with an expected survival prognosis of ≤1 year
  • Participation in a clinical study of another drug 30 days before hospitalization
  • Patients considered to require fasting at screening.
  • Other conditions likely to interfere with the patient's safety or compliance with the protocol
  • Other patients who are considered unsuitable by the principal investigator or other investigators

Trial locations and contacts

69 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuya Matsue, MD contact

81-3-3813-3111

yuya8950@gmail.com

69 sites in 1 country

Japan69 sites, 64 recruiting

  • Nishiarai Hospital

    Adachi City, Tokyo

    Active, not recruiting

  • Anjo Kosei Hospital

    Anjo, Aichi-ken

    Yusuke Uemura

    Recruiting

  • Fukuokaken Saiseikai Futsukaichi Hospital

    Chikushino-shi, Fukuoka

    Toshiaki Kadokami

    Recruiting

  • Mitsui Memorial Hospital

    Chiyoda City, Tokyo

    Yu Horiuchi

    Recruiting

  • Sakakibara Heart Institute

    Fuchū, Tokyo

    Mamoru Nanasato

    Recruiting

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, Fukuoka

    Hirohide Mastuura

    Recruiting

  • Iizuka Hospital

    Fukuoka

    Ryuichi Matsukawa, +81948-22-3800, ryu1matsukawa@gmail.com

    Recruiting

  • Funabashi Municipal Medical Center

    Funabashi, Chiba

    Shinichi Okino

    Recruiting

  • Gifu University Graduate school of Medicine

    Gifu

    Hiroyuki Okura

    Recruiting

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo

    Nobuhiro Tanaka

    Recruiting

  • Seirei Mikatahara General Hospital

    Hamamatsu, Shizuoka

    Keisuke Miyajima

    Recruiting

  • Hirosaki University Hospital

    Hirosaki, Aomori

    Yuichi Toyama

    Recruiting

  • Hiroshima City Hospital

    Hiroshima, Hiroshima

    Tadanao Higaki

    Recruiting

  • Nayoro City General Hospital Contact:

    Hokkaido

    Sarasa Toyoshima, +810165433101, sarasa.toyoshima@gmail.com

    Recruiting

  • Tokai University Hospital

    Isehara, Kanagawa

    Takeshi Ijichi

    Recruiting

  • Juntendo University Shizuoka Hospital

    Izunokuni, Shizuoka

    Satoru Suwa

    Recruiting

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa

    Shigeru Saito

    Recruiting

  • Kameda Medical Center

    Kamogawa, Chiba

    Akira Mizukami

    Recruiting

  • International Goodwill Hospital

    Kanagawa

    Zenko Nagashima, +8145-813-0221, zenskywalker29@gmail.com

    Recruiting

  • Kitasato University Hospital

    Kanagawa

    Takeru Nabeta

    Recruiting

  • SHOWA Medical University Fujigaoka Hospital

    Kanagawa

    Emi Ebata, +8145-971-1151, ippeiaki@med.showa-u.ac.jp

    Recruiting

  • Nara Medical University Hospital

    Kashihara, Nara

    Kazutaka Nogi

    Recruiting

  • Kasukabe Chuo General Hospital

    Kasukabe, Saitama

    Keisuke Nakabayashi

    Recruiting

  • Saitama Medical Center

    Kawagoe, Saitama

    Kentaro Jujo

    Recruiting

  • Kawaguchi Cardiovascular and Respiratory Hospital

    Kawaguchi, Saitama

    Eiichi Akiyama

    Recruiting

  • St.Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa

    Keisuke Kida

    Recruiting

  • Chikamori Hospital

    Kochi, Kochi

    Hayato Hosoda

    Recruiting

  • Kurume University Hospital

    Kurume, Fukuoka

    Tatsuhiro Shibata

    Recruiting

  • Kushiro-sanjikai Hospital

    Kushiro, Hokkaido

    Yoshikuni Obata

    Recruiting

  • Gunma University Hospital

    Maebashi, Gunma

    Masaru Obokata

    Recruiting

  • International University of Health and Welfare Mita Hospital

    Minato, Tokyo

    Yuichi Tamura

    Recruiting

  • Toranomon Hospital

    Minato, Tokyo

    Takahide Kodama

    Recruiting

  • Iwate Prefectural Cyuou Hospital

    Morioka, Iwate

    Masanobu Miura

    Recruiting

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken

    Tetsuya Amano

    Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi-ken

    Takahiro Okumura

    Recruiting

  • Kochi Medical School Hospital

    Nankoku, Kochi

    Toru Kubo

    Recruiting

  • Nara Prefecture General Medical Center

    Nara, Nara

    Kazuma Matsubayashi

    Recruiting

  • Ogaki Municipal Hospital

    Ōgaki, Gifu

    Naoki Watanabe

    Recruiting

  • Sakakibara Heart Institute of Okayama

    Okayama, Okayama-ken

    Atsushi Hirohata

    Recruiting

  • Nakagami Hospital

    Okinawa, Okinawa

    Active, not recruiting

  • Kitano Hospital

    Osaka, Osaka

    Shinya Ito

    Recruiting

  • Osaka General Medical Center

    Osaka, Osaka

    Atsushi Kikuchi

    Recruiting

  • Hanwa Memorial Hospital

    Osaka

    Takatoshi Hayashi, +816-6696-5591, hayashi.takatoshi@kinshukai.or.jp

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka

    Hideaki Morita, +8172-683-1221, hideaki.morita@ompu.ac.jp

    Recruiting

  • Saitama Citizens Medical Center

    Saitama, Saitama

    Active, not recruiting

  • Medical Corporation Sapporo Heart Center

    Sapporo, Hokkaido

    Daisuke Hachinohe

    Recruiting

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido

    Yutaro Kasai

    Recruiting

  • Kindai University Hospital

    Sayama, Osaka

    Koichiro Matsumura

    Recruiting

  • Tokyo Women's Medical University Hospital

    Shinjuku, Tokyo

    Atsushi Suzuki

    Recruiting

  • Soka City Hospital

    Sōka, Saitama

    Hiroshi Inagaki

    Recruiting

  • National Cerebral and Cardiovascular Center Hospital

    Suita, Osaka

    Takeshi Kitai

    Recruiting

  • Hyogo Prefectural Awaji Medical Center

    Sumoto, Awaji

    Active, not recruiting

  • National Disaster Medical Center

    Tachikawa, Tokyo

    Kazuto Hayasaka

    Recruiting

  • Tokushima University Hospital

    Tokushima, Tokushima

    Takayuki Ise

    Recruiting

  • Juntendo University Nerima Hospital

    Tokyo, Tokyo

    Kikuo Isoda

    Recruiting

  • Tokyo Metropolitan Bokutoh Hospital

    Tokyo, Tokyo

    Active, not recruiting

  • Juntendo University Hospital

    Tokyo

    Yuya Matsue

    Recruiting

  • Nihon University Itabashi Hospital

    Tokyo

    Daisuke Kitano

    Recruiting

  • Nippon Medical School Hospital

    Tokyo

    Yukihiro Watanabe

    Recruiting

  • St. Luke's International Hospital

    Tokyo

    Atsushi Mizuno

    Recruiting

  • The Jikei University Hospital

    Tokyo

    Yusuke Kashiwagi, +813-3433-1111, y-kashiwa@jikei.ac.jp

    Recruiting

  • Tokyo General Hospital

    Tokyo

    Hideyuki Takimura

    Recruiting

  • Tokyo Medical University

    Tokyo

    Masatake Kobayashi

    Recruiting

  • Tokyo Saiseikai Central Hospital

    Tokyo

    Toshiyuki Takahashi, +813-3451-8211, ttakahashi@saichu.jp

    Recruiting

  • Tsuchiura Kyodo General Hospital

    Tsuchiura, Ibaraki

    Tsunekazu Kakuta

    Recruiting

  • Urasoe General Hospital

    Urasoe, Okinawa

    Satoru Takaesu

    Recruiting

  • Juntendo University Urayasu Hospital

    Urayasu, Chiba

    Takashi Tokano

    Recruiting

  • Saiseikai Utsunomiya Hospital

    Utsunomiya, Tochigi

    Kenichiro Shimoji

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, Yokohama

    Kozo Okada

    Recruiting

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Empagliflozin in Patients With Acute Heart Failure

The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for patients with acute heart failure (AHF) who are at a high risk of adverse events.

Being tested
Empagliflozin 10 MG, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 10 MGDrug

    once-daily oral empagliflozin 10 mg

  • PlaceboDrug

    Placebo matching empagliflozin 10 mg

Study groups in NCT05392764
Study groupRoleWhat they receive
EmpagliflozinExperimentalPatients will be randomized 1:1 to either empagliflozin or placebo.
Receives: Drug: Empagliflozin 10 MG
PlaceboPlacebo comparatorPlacebo matching empagliflozin
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A hierarchical composite endpoint consisting of death within 90 days, heart failure rehospitalization within 90 days, WHF during hospitalization, and urine output up to 48 hours after treatment initiation, assessed by the win ratio

    WHF, worsening heart failure

    Measured: Up to 90 days

Secondary outcomes (17)

  1. A hierarchical composite endpoint consisting of death within 90 days, heart failure readmission within 90 days, and WHF during hospitalization

    WHF, worsening heart failure

    Measured: Up to 90 days

  2. A composite endpoint consisting of WHF during hospitalization, death, heart failure rehospitalization, urgent visit for WHF, intensification of diuretic therapy, and worsening NYHA class within 90 days

    WHF, worsening heart failure

    Measured: Up to 90 days

  3. Change in NT-proBNP from randomization to 48 hours

    Measured: Evaluated at 48 hours after randomization

  4. Diuretic response, calculated as urine output achieved by loop diuretics (40 mg intravenous furosemide-equivalent dose) at 48 h after treatment initiation

    Measured: Evaluated at 48 hours after randomization

  5. Improvement in KCCQ-TSS of ≥5 points from randomization to 30 and 90 days after treatment initiation

    KCCQ-TSS, Kansas City Cardiomyopathy Questionnaire - Total Symptom Score. The scores range from 0 to 100, with 100 being the best possible score.

    Measured: Up to 90 days

  6. Time to hemodynamic stabilization during index hospitalization

    Measured: During index hospitalization

  7. Re-worsening of heart failure during index hospitalization

    Measured: During index hospitalization

  8. Heart failure rehospitalization

    Measured: Up to 90 days

  9. Death

    Measured: Up to 90 days

  10. Urine output during the 48 h after randomization

    Measured: Evaluated at 48 hours after randomization

  11. Cardiovascular death

    Measured: Up to 90 days

  12. Change in the visual analog scale score for dyspnea from after randomization to 24 and 48 h

    The scores range from 0 to 100, with 100 being the best possible score.

    Measured: Evaluated at 24 and 48 hours after randomization

  13. Change in high sensitivity cardiac troponin T

    Measured: Evaluated at 48 hours after randomization

  14. Change in the KCCQ-TSS after randomization to 30 and 90 days

    KCCQ-TSS, Kansas City Cardiomyopathy Questionnaire - Total Symptom Score. The scores range from 0 to 100, with 100 being the best possible score.

    Measured: Up to 90 days

  15. Composite of renal replacement therapy, renal transplantation, eGFR <15 mL/min/1.73m2, ≥50% decrease in eGFR compared to the first sample or a ≥2-fold increase in creatinine level compared to the first sample within 90 days of randomization

    Measured: Up to 90 days

  16. Trend in eGFR after randomization to 24 h, 48 h, 30 days, and 90 days

    Measured: Up to 90 days

  17. Days alive and out of hospital (including those for reasons other than heart failure)

    Measured: Up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start10 Sep 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
444 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05392764
Sponsor's protocol ID
jRCTs031210682
Acronym
EMPA-AHF
Status last verified
Feb 2026
First submitted
14 May 2022
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin 10 MG in people with Acute Heart Failure, run by Juntendo University at 69 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 8 inclusion and 30 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 consisting of death within 90 days, heart failure rehospitalization within 90 days, WHF during hospitalization, and urine output up to 48 hours after treatment initiation, assessed by the win ratio (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05392764.

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 13 Feb 2026.

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