Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction
- Conditions
- Acute Myocardial Infarction
- Registration Number
- NCT03087773
- Lead Sponsor
- Medical University of Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Myocardial infarction with evidence of significant myocardial necrosis defined as a<br> rise in creatinine kinase >800 U/l and a troponin T-level (or troponin I-level) >10x<br> upper limit of normal (ULN). In addition at least 1 of the following criteria must<br> be the met:<br><br> - Symptoms of ischemia<br><br> - ECG (electrocardiogram) changes indicative of new ischemia (new ST-T changes or<br> new LBBB)<br><br> - Imaging evidence of new regional wall motion abnormality<br><br> 2. 18 - 80 years of age<br><br> 3. Informed consent has to be given in written form<br><br> 4. estimated glomerular filtration rate (eGFR) > 45 ml/min/1.73m2<br><br> 5. Blood pressure before first drug dosing: Riva Rocci (RR) systolic >110 mmHg<br><br> 6. Blood pressure before first drug dosing: Riva Rocci (RR) diastolic >70 mmHg<br><br> 7. =72h after myocardial infarction (after the performance of a coronary angiography)<br><br>Exclusion Criteria:<br><br> 1. Any other form of diabetes mellitus than type 2 diabetes mellitus, history of<br> diabetic ketoacidosis<br><br> 2. Blood potential hydrogen (pH) < 7,32<br><br> 3. Known allergy to SGLT-2 inhibitors<br><br> 4. Hemodynamic instability as defined by intravenous administration of catecholamine,<br> calcium sensitizers or phosphodiesterase inhibitors<br><br> 5. >1 episode of severe hypoglycemia within the last 6 months and treatment with<br> insulin or sulfonylurea<br><br> 6. Females of childbearing potential without adequate contraceptive methods (i.e.<br> sterilization, intrauterine device, vasectomized partner; or medical history of<br> hysterectomy)<br><br> 7. Acute symptomatic urinary tract infection (UTI) or genital infection<br><br> 8. Patients currently being treated with any SGLT-2 inhibitor or having received<br> treatment with any SGLT-2 inhibitor within the 4 weeks prior to the screening visit
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of Nt-proBNP (N-terminales Pro Brain Natriuretic Peptide) Levels
- Secondary Outcome Measures
Name Time Method Changes in Ejection Fraction;Changes in Left Ventricular End-diastolic Volume;Duration of Hospital Stay;Changes in E/è Ratio From Baseline to Week 26;Changes in Left Ventricular End-systolic Volume (LVESV) From Baselin to Week 26