Effect of Empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: Multi-Center placebo-controlled Double-Blind Randomized Trial
Not Applicable
- Conditions
- Type 2 diabetes with acute myocardial infarction
- Registration Number
- JPRN-UMIN000030158
- Lead Sponsor
- ippon Medical School Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
Not provided
Exclusion Criteria
1) Type 1 diabetes mellitus 2) Persistent atrial fibrillation 3) Insulin, glucagon-like peptide-1 analogue, or other SGLT2 inhibitors user 4) High dose of sulfonylurea (glimepiride > 2 mg, glibenclamide > 1.25 mg, gliclazide > 40 mg) 5) HbA1c >= 10% 6) History of diabetic ketoacidosis or diabetic coma within 3 months prior to the randomization 7) Renal dysfunction (eGFR < 45 mL/min/1.73m2) 8) Heart failure graded at NYHA functional class IV 9) Pregnancy or possible pregnancy and breast feeding 10) Lack of informed consent 11) Patients judged by the investigator to be ineligible for inclusion in this study 12) Contraindicated for administration of empagliflozin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change from baseline of HRV at 24 weeks treatment between two groups 1) Time domain analysis [mean RR interval for 24 h (mean NN), standard deviation of normal RR intervals (SDNN), standard deviation of all 5-min mean normal RR intervals (SDANN), square root of the mean of the sum of the squares of differences between adjacent RR intervals (r-MSSD), and percentage of adjacent RR intervals differing > 50 ms (pNN50)] 2) Frequency domain analysis: [Total power (TP, 0-0.4 Hz), high-frequency (HF, 0.15-0.4 Hz), low-frequency (LF, 0.04-0.15 Hz), and sympathovagal balance (LF/HF ratio)]
- Secondary Outcome Measures
Name Time Method To compare the change from baseline in the clinical tests listed in the followings at 24 weeks treatment between two groups 1) TWA, LP, and HRT assessed by Ambulatory ECG (SCM-8000) 2) Cardiac sympathetic activity assessed by 123I-MIBG Scintigraphy 3) Blood pressure, body weight, BMI, HbA1c (NGSP), fasting plasma glucose, Serum lipids [TC, LDL-C (direct method), HDL-C, TG, and non-HDL-C], AST, ALT, gamma-GTP, UA, serum creatinine, eGFR (adjusted value), NT-pro BNP, serum ketone body (venous blood), and blood count (RBC, WBC, hemoglobin, hematocrit, and platelet), cystatin C, hs-CRP 4) Body fluid volume assessed by InBody