Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure
NCT ID: NCT05392764
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
524 participants
INTERVENTIONAL
2022-09-10
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Empagliflozin
Patients will be randomized 1:1 to either empagliflozin or placebo.
Empagliflozin 10 MG
once-daily oral empagliflozin 10 mg
Placebo
Placebo matching empagliflozin
Placebo
Placebo matching empagliflozin 10 mg
Interventions
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Empagliflozin 10 MG
once-daily oral empagliflozin 10 mg
Placebo
Placebo matching empagliflozin 10 mg
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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)
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
20 Years
89 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Juntendo University
OTHER
Responsible Party
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Yuya Matsue
Associate Professor
Principal Investigators
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Yuya Matsue, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine
Locations
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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
Kurume University Hospital
Kurume, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, 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
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Urasoe General Hospital
Urasoe, Okinawa, 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
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
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
Japanese Red Cross Fukuoka Hospital
Fukuoka, , Japan
Gifu University Graduate school of Medicine
Gifu, , Japan
Hiroshima City Hospital
Hiroshima, , Japan
Kitasato University Hospital
Kanagawa, , Japan
Chikamori Hospital
Kochi, , Japan
Nara Prefecture General Medical Center
Nara, , Japan
Sakakibara Heart Institute of Okayama
Okayama, , Japan
Nakagami Hospital
Okinawa, , Japan
Kitano Hospital
Osaka, , Japan
Osaka General Medical Center
Osaka, , Japan
Saitama Citizens Medical Center
Saitama, , Japan
Tokushima University Hospital
Tokushima, , Japan
Juntendo University Hospital
Tokyo, , Japan
Juntendo University Nerima Hospital
Tokyo, , Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
St. Luke's International Hospital
Tokyo, , Japan
Tokyo General Hospital
Tokyo, , Japan
Tokyo Medical University
Tokyo, , Japan
Tokyo Metropolitan Bokutoh Hospital
Tokyo, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Countries
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Central Contacts
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Facility Contacts
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Yusuke Uemura
Role: primary
Tetsuya Amano
Role: primary
Takahiro Okumura
Role: primary
Yuichi Toyama
Role: primary
Koji Kuroda
Role: primary
Shinichi Okino
Role: primary
Akira Mizukami
Role: primary
Takashi Tokano
Role: primary
Ken Onitsuka
Role: primary
Tatsuhiro Shibata
Role: primary
Naoki Watanabe
Role: primary
Masaru Obokata
Role: primary
Yoshikuni Obata
Role: primary
Daisuke Hachinohe
Role: primary
Yutaro Kasai
Role: primary
Tsunekazu Kakuta
Role: primary
Masanobu Miura
Role: primary
Takeshi Ijichi
Role: primary
Shigeru Saito
Role: primary
Keisuke Kida
Role: primary
Toru Kubo
Role: primary
Kazutaka Nogi
Role: primary
Masami Abe
Role: primary
Koichiro Matsumura
Role: primary
Takeshi Kitai
Role: primary
Keisuke Nakabayashi
Role: primary
Kentaro Jujo
Role: primary
Eiichi Akiyama
Role: primary
Hiroshi Inagaki
Role: primary
Keisuke Miyajima
Role: primary
Satoru Suwa
Role: primary
Kenichiro Shimoji
Role: primary
Jujo Kentaro
Role: primary
Yu Horiuchi
Role: primary
Mamoru Nanasato
Role: primary
Nobuhiro Tanaka
Role: primary
Yuichi Tamura
Role: primary
Takahide Kodama
Role: primary
Atsushi Suzuki
Role: primary
Kazuto Hayasaka
Role: primary
Ryuichi Matsukawa
Role: primary
Hiroyuki Okura
Role: primary
Tadanao Higaki
Role: primary
Takeru Nabeta
Role: primary
Hayato Hosoda
Role: primary
Kazuma Matsubayashi
Role: primary
Atsushi Hirohata
Role: primary
Satoshi Yamaguchi
Role: primary
Shinya Ito
Role: primary
Atsushi Kikuchi
Role: primary
Tomohiro Nakamura
Role: primary
Takayuki Ise
Role: primary
Yuya Matsue
Role: primary
Kikuo Isoda
Role: primary
Daisuke Kitano
Role: primary
Yukihiro Watanabe
Role: primary
Atsushi Mizuno
Role: primary
Hideyuki Takimura
Role: primary
Masatake Kobayashi
Role: primary
Koichi Ohashi
Role: primary
Kozo Okada
Role: primary
Other Identifiers
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jRCTs031210682
Identifier Type: -
Identifier Source: org_study_id
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