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Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT05392764•Juntendo University

View on ClinicalTrials.gov

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

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+19 more criteria

Locations (69)

Anjo Kosei Hospital

Anjo, Aichi-ken, Japan

Aichi Medical University Hospital

Nagakute, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Hyogo Prefectural Awaji Medical Center

Sumoto, Awaji, Japan

Funabashi Municipal Medical Center

Funabashi, Chiba, Japan

Kameda Medical Center

Kamogawa, Chiba, Japan

Juntendo University Urayasu Hospital

Urayasu, Chiba, Japan

Fukuokaken Saiseikai Futsukaichi Hospital

Chikushino-shi, Fukuoka, Japan

Japanese Red Cross Fukuoka Hospital

Fukuoka, Fukuoka, Japan

Key Dates

Start Date

September 10, 2022

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

February 13, 2026

Enrollment

444

ESTIMATED participants

Conditions

Acute Heart Failure

Interventions

Empagliflozin 10 MG

DRUG

Placebo

DRUG

Contacts

Yuya Matsue, MD

CONTACT

81-3-3813-3111 yuya8950@gmail.com

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Respiratory Virus Infections in Acute Heart Failure

Digoxin After Acute Heart Failure

MRI Assessment of Pulmonary Edema in Acute Heart Failure

Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography

Predictors of Acute Kidney Injury in Patients With Acute Decompensated Heart Failure in Emergency