Actively Recruiting
Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure
Led by Juntendo University · Updated on 2026-02-13
444
Participants Needed
69
Research Sites
276 weeks
Total Duration
On this page
Sponsors
J
Juntendo University
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Hospitalized with acute heart failure requiring intravenous loop diuretic therapy
- Presence of dyspnea at rest or with slight exertion
- At least two of the following: jugular venous distention, pulmonary rales, lower leg edema, pulmonary congestion on chest X-ray
- Elevated BNP or NT-proBNP levels according to heart rhythm and medication status
- At least one of the following: eGFR less than 60 mL/min/1.73m2, taking 40 mg or more of oral furosemide before hospitalization, or urine output less than 300 mL in 2 hours after intravenous furosemide
- Provided written consent to participate
- Mini-Cog score of 3 or higher if aged 90 or older with cognitive concerns
You will not qualify if you...
- eGFR less than 20 mL/min/1.73m2 at admission
- Use of SGLT2 inhibitors within 3 months prior to hospitalization
- Diagnosis of type 1 diabetes mellitus
- Systolic blood pressure below 90 mmHg
- Expected need for thiazide, tolvaptan, or carperitide treatment within 48 hours after study drug
- Main cause of heart failure hospitalization not due to fluid retention
- Recent acute coronary syndrome, pulmonary thromboembolism, or cerebrovascular accident
- Risk of ketoacidosis or hyperosmolar hyperglycemia
- Current dialysis or planned dialysis initiation during hospitalization
- Pregnant or breastfeeding women
- Recent cardiovascular surgery or device implantation within 30 days
- Recent diagnosis of acute coronary syndrome, cerebral infarction, or transient ischemic attack within 90 days
- Ventricular tachycardia with syncope within 90 days
- Heart transplant recipient or candidate expecting transplant
- Intubation at screening or expected within 48 hours
- Severe valvular heart disease requiring surgery or catheterization
- Secondary cardiomyopathy diagnoses or other specified heart conditions
- Recent peripartum cardiomyopathy diagnosis
- Active myocarditis
- Uncontrolled thyroid disease
- Acute cardiac structural abnormalities
- Symptomatic bradycardia or complete atrioventricular block requiring temporary pacemaker
- Serious liver disorder or cirrhosis with portal hypertension
- Alcohol use disorder of mild or greater severity
- Active or suspected malignancy within 2 years
- Coexisting diseases with expected survival less than 1 year
- Participation in another drug clinical study within 30 days
- Requirement for fasting at screening
- Other conditions affecting safety or protocol compliance
- Considered unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 69 locations
1
Anjo Kosei Hospital
Anjo, Aichi-ken, Japan
Actively Recruiting
2
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Actively Recruiting
3
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Actively Recruiting
4
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Actively Recruiting
5
Hyogo Prefectural Awaji Medical Center
Sumoto, Awaji, Japan
Active, Not Recruiting
6
Funabashi Municipal Medical Center
Funabashi, Chiba, Japan
Actively Recruiting
7
Kameda Medical Center
Kamogawa, Chiba, Japan
Actively Recruiting
8
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan
Actively Recruiting
9
Fukuokaken Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka, Japan
Actively Recruiting
10
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, Japan
Actively Recruiting
11
Kurume University Hospital
Kurume, Fukuoka, Japan
Actively Recruiting
12
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Actively Recruiting
13
Gunma University Hospital
Maebashi, Gunma, Japan
Actively Recruiting
14
Hiroshima City Hospital
Hiroshima, Hiroshima, Japan
Actively Recruiting
15
Kushiro-sanjikai Hospital
Kushiro, Hokkaido, Japan
Actively Recruiting
16
Medical Corporation Sapporo Heart Center
Sapporo, Hokkaido, Japan
Actively Recruiting
17
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
18
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaraki, Japan
Actively Recruiting
19
Iwate Prefectural Cyuou Hospital
Morioka, Iwate, Japan
Actively Recruiting
20
Tokai University Hospital
Isehara, Kanagawa, Japan
Actively Recruiting
21
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Actively Recruiting
22
St.Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Actively Recruiting
23
Chikamori Hospital
Kochi, Kochi, Japan
Actively Recruiting
24
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Actively Recruiting
25
Nara Medical University Hospital
Kashihara, Nara, Japan
Actively Recruiting
26
Nara Prefecture General Medical Center
Nara, Nara, Japan
Actively Recruiting
27
Sakakibara Heart Institute of Okayama
Okayama, Okayama-ken, Japan
Actively Recruiting
28
Nakagami Hospital
Okinawa, Okinawa, Japan
Active, Not Recruiting
29
Urasoe General Hospital
Urasoe, Okinawa, Japan
Actively Recruiting
30
Kitano Hospital
Osaka, Osaka, Japan
Actively Recruiting
31
Osaka General Medical Center
Osaka, Osaka, Japan
Actively Recruiting
32
Kindai University Hospital
Sayama, Osaka, Japan
Actively Recruiting
33
National Cerebral and Cardiovascular Center Hospital
Suita, Osaka, Japan
Actively Recruiting
34
Kasukabe Chuo General Hospital
Kasukabe, Saitama, Japan
Actively Recruiting
35
Saitama Medical Center
Kawagoe, Saitama, Japan
Actively Recruiting
36
Kawaguchi Cardiovascular and Respiratory Hospital
Kawaguchi, Saitama, Japan
Actively Recruiting
37
Saitama Citizens Medical Center
Saitama, Saitama, Japan
Active, Not Recruiting
38
Soka City Hospital
Sōka, Saitama, Japan
Actively Recruiting
39
Seirei Mikatahara General Hospital
Hamamatsu, Shizuoka, Japan
Actively Recruiting
40
Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka, Japan
Actively Recruiting
41
Saiseikai Utsunomiya Hospital
Utsunomiya, Tochigi, Japan
Actively Recruiting
42
Tokushima University Hospital
Tokushima, Tokushima, Japan
Actively Recruiting
43
Nishiarai Hospital
Adachi City, Tokyo, Japan
Active, Not Recruiting
44
Mitsui Memorial Hospital
Chiyoda City, Tokyo, Japan
Actively Recruiting
45
Sakakibara Heart Institute
Fuchū, Tokyo, Japan
Actively Recruiting
46
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, Japan
Actively Recruiting
47
International University of Health and Welfare Mita Hospital
Minato, Tokyo, Japan
Actively Recruiting
48
Toranomon Hospital
Minato, Tokyo, Japan
Actively Recruiting
49
Tokyo Women's Medical University Hospital
Shinjuku, Tokyo, Japan
Actively Recruiting
50
National Disaster Medical Center
Tachikawa, Tokyo, Japan
Actively Recruiting
51
Juntendo University Nerima Hospital
Tokyo, Tokyo, Japan
Actively Recruiting
52
Tokyo Metropolitan Bokutoh Hospital
Tokyo, Tokyo, Japan
Active, Not Recruiting
53
Yokohama City University Medical Center
Yokohama, Yokohama, Japan
Actively Recruiting
54
Iizuka Hospital
Fukuoka, Japan
Actively Recruiting
55
Gifu University Graduate school of Medicine
Gifu, Japan
Actively Recruiting
56
Nayoro City General Hospital Contact:
Hokkaido, Japan
Actively Recruiting
57
International Goodwill Hospital
Kanagawa, Japan
Actively Recruiting
58
Kitasato University Hospital
Kanagawa, Japan
Actively Recruiting
59
SHOWA Medical University Fujigaoka Hospital
Kanagawa, Japan
Actively Recruiting
60
Hanwa Memorial Hospital
Osaka, Japan
Actively Recruiting
61
Osaka Medical and Pharmaceutical University Hospital
Osaka, Japan
Actively Recruiting
62
Juntendo University Hospital
Tokyo, Japan
Actively Recruiting
63
Nihon University Itabashi Hospital
Tokyo, Japan
Actively Recruiting
64
Nippon Medical School Hospital
Tokyo, Japan
Actively Recruiting
65
St. Luke's International Hospital
Tokyo, Japan
Actively Recruiting
66
The Jikei University Hospital
Tokyo, Japan
Actively Recruiting
67
Tokyo General Hospital
Tokyo, Japan
Actively Recruiting
68
Tokyo Medical University
Tokyo, Japan
Actively Recruiting
69
Tokyo Saiseikai Central Hospital
Tokyo, Japan
Actively Recruiting
Research Team
Y
Yuya Matsue, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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