SGLT2 inhibitor versus DPP-4 inhibitor on left ventricular ejection fraction measured by echocardiography in diabetic patients with acute myocardial infarction and midranged ejection fraction (EMPA-MI-MREF)
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007622
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 600
1) 19 years of age or older
2) Left ventricular ejection fraction of 40~49% in echocardiography performed within 30 days of diagnosis of acute myocardial infarction
3) Those diagnosed with type 2 diabetes and covered by SGLT2 inhibitor and DPP4 inhibitor insurance -> If metformin is stably administered for at least 12 weeks before participating in the trial and the HbA1c is 7.0% or higher, or If you are taking the second diabetes drug (Metformin + [sulfonylurea, Meglitinide, alpha-glucodase inhibitor, Thiazolidinedione, DPP4 inhibitor])
4) When consent to participate in clinical trial
1) Patients with hypersensitivity to SGLT-2 inhibitors
2) Patients taking SGLT-2 inhibitors continuously
3) Patients with type 1 diabetes or those who need insulin supply
4) glomerular filtration rate (eGFR) <45 mL/min/1.73m 2 (MDRD formula), patients with end stage renal disease (ESRD) or patients on dialysis
5) Patients with severe liver dysfunction including cirrhosis patients (hepatic enzyme levels more than 3 times the upper limit of normal)
6) Patients who are taking drugs that can significantly affect blood sugar control (such as systemic corticosteroids) or are expected to take them during the trial period
7) Women of childbearing potential who has a plan to become pregnant during clinical trials, or do not intend to use appropriate contraceptive methods
8) Subjects who visited the hospital for cardiac arrest or cardiogenic shock before randomization, and whose survival is judged to be low.
9) Persons diagnosed with heart failure before randomization
10) You are participating in another randomized controlled study, or you are participating in an observational study that may affect the study.
11) Those whose remaining life expectancy is less than 1 year or who are expected to have low adherence to treatment
12) Those who are judged by other investigators to be inappropriate to participate in clinical trials.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in left ventricular ejection fraction in echocardiography in patients with acute myocardial infarction
- Secondary Outcome Measures
Name Time Method left ventricular end-systolic volume in echocardiography, left ventricular end-diastolic volume in echocardiography, myocardial blood flow reserve in PET, dyspnea NYHA classification , HbA1c, NT-proBNP, renal function, cardiac death or readmission due to heart failure, all deaths or readmission due to heart failure, target lesion failure, target vessel failure (TVF; composite of cardiac death, myocardial infarction, and clinically indicated percutaneous or surgical target vessel revascularization), patient-oriented composite outcome, all deaths, cardiac death, myocardial infarction, targeted lesion revascularization, target vessel revascularization, readmission due to heart failure.