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

Status: Recruiting
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 89
Healthy Volunteers: f
View:

⁃ Patients who meet the below inclusion criteria will be randomized within 12 h after presentation to the hospital

• Age of ≥20 and \<90 years

• 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.

• 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.

• Provided written consent to participate in the study

Locations
Other Locations
Japan
Nishiarai Hospital
RECRUITING
Adachi City
Anjo Kosei Hospital
RECRUITING
Anjo
Fukuokaken Saiseikai Futsukaichi Hospital
RECRUITING
Chikushino-shi
Mitsui Memorial Hospital
RECRUITING
Chiyoda City
Sakakibara Heart Institute
RECRUITING
Fuchū
Japanese Red Cross Fukuoka Hospital
RECRUITING
Fukuoka
Funabashi Municipal Medical Center
RECRUITING
Funabashi
Gifu University Graduate school of Medicine
RECRUITING
Gifu
Tokyo Medical University Hachioji Medical Center
RECRUITING
Hachiōji
Seirei Mikatahara General Hospital
RECRUITING
Hamamatsu
Hirosaki University Hospital
RECRUITING
Hirosaki
Hiroshima City Hospital
RECRUITING
Hiroshima
Tokai University Hospital
RECRUITING
Isehara
Juntendo University Shizuoka Hospital
RECRUITING
Izunokuni
Shonan Kamakura General Hospital
RECRUITING
Kamakura
Kameda Medical Center
RECRUITING
Kamogawa
Kitasato University Hospital
RECRUITING
Kanagawa
Nara Medical University Hospital
RECRUITING
Kashihara
Kasukabe Chuo General Hospital
RECRUITING
Kasukabe
Saitama Medical Center
RECRUITING
Kawagoe
Kawaguchi Cardiovascular and Respiratory Hospital
RECRUITING
Kawaguchi
St.Marianna University School of Medicine Hospital
RECRUITING
Kawasaki
Chikamori Hospital
RECRUITING
Kochi
Kurume University Hospital
RECRUITING
Kurume
Kushiro-sanjikai Hospital
RECRUITING
Kushiro
Gunma University Hospital
RECRUITING
Maebashi
International University of Health and Welfare Mita Hospital
RECRUITING
Minato
Toranomon Hospital
NOT_YET_RECRUITING
Minato
Iwate Prefectural Cyuou Hospital
RECRUITING
Morioka
Aichi Medical University Hospital
RECRUITING
Nagakute
Nagoya University Hospital
RECRUITING
Nagoya
Kochi Medical School Hospital
RECRUITING
Nankoku
Nara Prefecture General Medical Center
RECRUITING
Nara
Ogaki Municipal Hospital
RECRUITING
Ōgaki
Sakakibara Heart Institute of Okayama
RECRUITING
Okayama
Nakagami Hospital
RECRUITING
Okinawa
Kitano Hospital
RECRUITING
Osaka
Osaka General Medical Center
RECRUITING
Osaka
Saitama Citizens Medical Center
RECRUITING
Saitama
Medical Corporation Sapporo Heart Center
RECRUITING
Sapporo
Sapporo Higashi Tokushukai Hospital
RECRUITING
Sapporo
Kindai University Hospital
RECRUITING
Sayama
Tokyo Women's Medical University Hospital
RECRUITING
Shinjuku
Soka City Hospital
RECRUITING
Sōka
National Cerebral and Cardiovascular Center Hospital
RECRUITING
Suita
Hyogo Prefectural Awaji Medical Center
RECRUITING
Sumoto
National Disaster Medical Center
RECRUITING
Tachikawa
Tokushima University Hospital
RECRUITING
Tokushima
Juntendo University Hospital
RECRUITING
Tokyo
Juntendo University Nerima Hospital
RECRUITING
Tokyo
Nihon University Itabashi Hospital
RECRUITING
Tokyo
Nippon Medical School Hospital
RECRUITING
Tokyo
St. Luke's International Hospital
RECRUITING
Tokyo
Tokyo General Hospital
RECRUITING
Tokyo
Tokyo Medical University
RECRUITING
Tokyo
Tokyo Metropolitan Bokutoh Hospital
RECRUITING
Tokyo
Tsuchiura Kyodo General Hospital
RECRUITING
Tsuchiura
Urasoe General Hospital
RECRUITING
Urasoe
Juntendo University Urayasu Hospital
RECRUITING
Urayasu
Saiseikai Utsunomiya Hospital
RECRUITING
Utsunomiya
Yokohama City University Medical Center
RECRUITING
Yokohama
Contact Information
Primary
Yuya Matsue, MD
yuya8950@gmail.com
81-3-3813-3111
Time Frame
Start Date: 2022-09-10
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 524
Treatments
Experimental: Empagliflozin
Patients will be randomized 1:1 to either empagliflozin or placebo.
Placebo_comparator: Placebo
Placebo matching empagliflozin
Related Therapeutic Areas
Sponsors
Collaborators: Boehringer Ingelheim
Leads: Juntendo University

This content was sourced from clinicaltrials.gov