Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Empagliflozin in Patients With Acute Heart Failure
Led by Juntendo University · Updated on 2026-02-13
444
Participants Needed
69
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Juntendo University
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the early use of empagliflozin, taken once daily by mouth, in patients hospitalized with acute heart failure who are at high risk of complications. This Phase 3, multicenter, randomized, double-blind trial compares empagliflozin to a placebo to assess its safety and effectiveness. The study is sponsored by Juntendo University and focuses on important outcomes like death, rehospitalization, worsening heart failure, and urine output within 90 days of treatment. Participants will be randomly assigned to receive either empagliflozin 10 mg once daily or a matching placebo. Treatment begins within 12 hours of hospital presentation. Both groups will be closely monitored during hospitalization and for up to 90 days after starting the study drug. The study uses a quadruple-blind design, meaning patients, caregivers, investigators, and assessors do not know which treatment is given. During the study, participants will undergo various assessments including monitoring of heart failure symptoms, urine output, blood tests for heart and kidney function, and quality of life questionnaires. Researchers will measure outcomes such as death rates, heart failure rehospitalizations, symptom changes, and kidney function over 90 days. Safety will be closely tracked throughout the study period. Total participation time varies but includes hospital stay and follow-up visits up to 90 days.
CONDITIONS
Brief 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
- Symptoms of dyspnea at rest or with slight exertion
- At least two of the following signs: jugular venous distention, pulmonary rales, leg edema, or pulmonary congestion on chest X-ray
- BNP or NT-proBNP levels meeting specified thresholds based on heart rhythm
- At least one of: eGFR below 60 mL/min/1.73m2, taking 40 mg or more oral furosemide before hospitalization, or low urine output after intravenous diuretic
- Provided written consent to participate
- For patients aged 90 or older, cognitive function confirmed by Mini-Cog score of 3 or higher
You will not qualify if you...
- eGFR below 20 mL/min/1.73m2 at admission
- Use of SGLT2 inhibitors within 3 months before hospitalization
- Diagnosis of type 1 diabetes mellitus
- Systolic blood pressure below 90 mmHg
- Expected need for thiazide, tolvaptan, or carperitide within 48 hours of study drug
- Acute heart failure hospitalization caused by conditions other than fluid retention
- Acute coronary syndrome, pulmonary embolism, or stroke as main cause of hospitalization
- Risk of ketoacidosis or hyperosmolar hyperglycemia
- On or planned to start dialysis
- Pregnant or breastfeeding women
- Recent major cardiovascular surgery or device implantation
- Recent diagnosis of acute coronary syndrome, stroke, or ventricular tachycardia with syncope
- Heart transplant recipients or candidates expected to undergo transplant
- Intubated or expected to require intubation within 48 hours
- Severe valvular heart disease needing surgery or catheterization
- Secondary cardiomyopathy or specific heart diseases listed
- Recent diagnosis of peripartum cardiomyopathy
- Active myocarditis
- Uncontrolled thyroid disease
- Acute cardiac structural abnormalities
- Symptomatic bradycardia needing temporary pacemaker
- Serious liver disorders or cirrhosis with portal hypertension
- Alcohol use disorder of mild or greater severity
- Active or suspected malignancy within 2 years
- Other diseases with life expectancy under 1 year
- Participation in another drug study within 30 days
- Requirement for fasting at screening
- Conditions interfering with safety or compliance
- Other reasons deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 90 days
Participants receive once-daily oral empagliflozin 10 mg or placebo as part of the study treatment for acute heart failure.
Multiple visits during hospitalization and follow-up over 90 days
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
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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