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RecruitingPhase 3NCT05392764

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

Sponsor

Juntendo University

Enrollment

444 participants

Start Date

Sep 10, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Heart Failure

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether starting an SGLT2 inhibitor pill — a medication class (including empagliflozin and dapagliflozin) originally developed for diabetes but now proven to benefit heart failure — very early during a hospital admission for acute heart failure can help patients recover better and reduce the risk of worsening or readmission. **You may be eligible if...** - You are 20 or older - You have been admitted to hospital with a diagnosis of acute heart failure - You are being considered for this medication within 12 hours of arriving at the hospital **You may NOT be eligible if...** - Your kidney function is severely reduced (eGFR below 20) - You have been taking an SGLT2 inhibitor drug in the past 3 months - You have type 1 diabetes mellitus - Your blood pressure is critically low (systolic below 90 mmHg) - You have a serious genital or urinary tract infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 10 MG

once-daily oral empagliflozin 10 mg

DRUGPlacebo

Placebo matching empagliflozin 10 mg

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

Kurume University Hospital

Kurume, Fukuoka, Japan

Ogaki Municipal Hospital

Ōgaki, Gifu, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Hiroshima City Hospital

Hiroshima, Hiroshima, Japan

Kushiro-sanjikai Hospital

Kushiro, Hokkaido, Japan

Medical Corporation Sapporo Heart Center

Sapporo, Hokkaido, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Tsuchiura Kyodo General Hospital

Tsuchiura, Ibaraki, Japan

Iwate Prefectural Cyuou Hospital

Morioka, Iwate, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

St.Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Chikamori Hospital

Kochi, Kochi, Japan

Kochi Medical School Hospital

Nankoku, Kochi, Japan

Nara Medical University Hospital

Kashihara, Nara, Japan

Nara Prefecture General Medical Center

Nara, Nara, Japan

Sakakibara Heart Institute of Okayama

Okayama, Okayama-ken, Japan

Nakagami Hospital

Okinawa, Okinawa, Japan

Urasoe General Hospital

Urasoe, Okinawa, Japan

Kitano Hospital

Osaka, Osaka, Japan

Osaka General Medical Center

Osaka, Osaka, Japan

Kindai University Hospital

Sayama, Osaka, Japan

National Cerebral and Cardiovascular Center Hospital

Suita, Osaka, Japan

Kasukabe Chuo General Hospital

Kasukabe, Saitama, Japan

Saitama Medical Center

Kawagoe, Saitama, Japan

Kawaguchi Cardiovascular and Respiratory Hospital

Kawaguchi, Saitama, Japan

Saitama Citizens Medical Center

Saitama, Saitama, Japan

Soka City Hospital

Sōka, Saitama, Japan

Seirei Mikatahara General Hospital

Hamamatsu, Shizuoka, Japan

Juntendo University Shizuoka Hospital

Izunokuni, Shizuoka, Japan

Saiseikai Utsunomiya Hospital

Utsunomiya, Tochigi, Japan

Tokushima University Hospital

Tokushima, Tokushima, Japan

Nishiarai Hospital

Adachi City, Tokyo, Japan

Mitsui Memorial Hospital

Chiyoda City, Tokyo, Japan

Sakakibara Heart Institute

Fuchū, Tokyo, Japan

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, Japan

International University of Health and Welfare Mita Hospital

Minato, Tokyo, Japan

Toranomon Hospital

Minato, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku, Tokyo, Japan

National Disaster Medical Center

Tachikawa, Tokyo, Japan

Juntendo University Nerima Hospital

Tokyo, Tokyo, Japan

Tokyo Metropolitan Bokutoh Hospital

Tokyo, Tokyo, Japan

Yokohama City University Medical Center

Yokohama, Yokohama, Japan

Iizuka Hospital

Fukuoka, Japan

Gifu University Graduate school of Medicine

Gifu, Japan

Nayoro City General Hospital Contact:

Hokkaido, Japan

International Goodwill Hospital

Kanagawa, Japan

Kitasato University Hospital

Kanagawa, Japan

SHOWA Medical University Fujigaoka Hospital

Kanagawa, Japan

Hanwa Memorial Hospital

Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Osaka, Japan

Juntendo University Hospital

Tokyo, Japan

Nihon University Itabashi Hospital

Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Japan

St. Luke's International Hospital

Tokyo, Japan

The Jikei University Hospital

Tokyo, Japan

Tokyo General Hospital

Tokyo, Japan

Tokyo Medical University

Tokyo, Japan

Tokyo Saiseikai Central Hospital

Tokyo, Japan

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NCT05392764

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