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Clinical Trials in Japan / NCT05392764
Recruiting Phase 3

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

NCT05392764 · tracked via the Priya Life Science Japan tracker
Sponsor
Juntendo University
Phase
Phase 3
Started
2022-09-10
Last updated
2026-02-13

Condition(s) studied

Acute Heart Failure

Investigational drug(s) / intervention(s)

Empagliflozin 10 MG →Placebo

Empagliflozin 10 MG: once-daily oral empagliflozin 10 mg

Placebo: Placebo matching empagliflozin 10 mg

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (69)

FacilityCityRegionStatus
Anjo Kosei Hospital Anjo Aichi-ken Recruiting
Aichi Medical University Hospital Nagakute Aichi-ken Recruiting
Nagoya University Hospital Nagoya Aichi-ken Recruiting
Hirosaki University Hospital Hirosaki Aomori Recruiting
Hyogo Prefectural Awaji Medical Center Sumoto Awaji Active Not Recruiting
Funabashi Municipal Medical Center Funabashi Chiba Recruiting
Kameda Medical Center Kamogawa Chiba Recruiting
Juntendo University Urayasu Hospital Urayasu Chiba Recruiting
Fukuokaken Saiseikai Futsukaichi Hospital Chikushino-shi Fukuoka Recruiting
Japanese Red Cross Fukuoka Hospital Fukuoka Fukuoka Recruiting
Kurume University Hospital Kurume Fukuoka Recruiting
Ogaki Municipal Hospital Ōgaki Gifu Recruiting
Gunma University Hospital Maebashi Gunma Recruiting
Hiroshima City Hospital Hiroshima Hiroshima Recruiting
Kushiro-sanjikai Hospital Kushiro Hokkaido Recruiting
Medical Corporation Sapporo Heart Center Sapporo Hokkaido Recruiting
Sapporo Higashi Tokushukai Hospital Sapporo Hokkaido Recruiting
Tsuchiura Kyodo General Hospital Tsuchiura Ibaraki Recruiting
Iwate Prefectural Cyuou Hospital Morioka Iwate Recruiting
Tokai University Hospital Isehara Kanagawa Recruiting
Shonan Kamakura General Hospital Kamakura Kanagawa Recruiting
St.Marianna University School of Medicine Hospital Kawasaki Kanagawa Recruiting
Chikamori Hospital Kochi Kochi Recruiting
Kochi Medical School Hospital Nankoku Kochi Recruiting
Nara Medical University Hospital Kashihara Nara Recruiting
Nara Prefecture General Medical Center Nara Nara Recruiting
Sakakibara Heart Institute of Okayama Okayama Okayama-ken Recruiting
Nakagami Hospital Okinawa Okinawa Active Not Recruiting
Urasoe General Hospital Urasoe Okinawa Recruiting
Kitano Hospital Osaka Osaka Recruiting
Osaka General Medical Center Osaka Osaka Recruiting
Kindai University Hospital Sayama Osaka Recruiting
National Cerebral and Cardiovascular Center Hospital Suita Osaka Recruiting
Kasukabe Chuo General Hospital Kasukabe Saitama Recruiting
Saitama Medical Center Kawagoe Saitama Recruiting
Kawaguchi Cardiovascular and Respiratory Hospital Kawaguchi Saitama Recruiting
Saitama Citizens Medical Center Saitama Saitama Active Not Recruiting
Soka City Hospital Sōka Saitama Recruiting
Seirei Mikatahara General Hospital Hamamatsu Shizuoka Recruiting
Juntendo University Shizuoka Hospital Izunokuni Shizuoka Recruiting

+ 29 more sites — see the full list on the official registry below.

More Juntendo University trials in Japan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05392764 on ClinicalTrials.gov ↗ ← All trials in Japan