Myocardial infarction
Conditions
Interventions
Trade Name: Jardiance (Empagliflozin)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EMPAGLIFLOZIN
CAS Number: 864070-44-0
Current Sponsor code: HS-2017-01
Other descriptive name: EMPAGL
Sponsors
Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Myocardial infarction with evidence of significant myocardial necrosis defined as a rise in creatinine kinase >800 U/l and a troponin T- or I level >10x ULN. In addition at least 1 of the following criteria must be met: - Symptoms of ischemia - ECG changes indicative of new ischemia (new ST-T changes or new LBBB) - Imaging evidence of new regional wall motion abnormality 2)18 – 80 years of age 3)Informed consent has to be given in written form. 4)eGFR > 45 ml/min/1.73m2 5)Blood pressure before first drug dosing >110 mmHg 6)Blood pressure before first drug dosing >70 mmHg 7)First intake of study medication =72h after myocardial infarction Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 176
Exclusion criteria
Exclusion criteria: 1)Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis 2)Blood pH 1 episode of severe hypoglycemia within the last 6 months and treatment with insulin or sulfonylurea 6)Females of child bearing potential without adequate contraceptive methods (i.e. sterilisation, intrauterine device, vasectimized partner; or medical history of hysterectomy) 7)Acute symptomatic urinary tract infection (UTI) or genital infection 8)Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 4 weeks prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the impact of Empagliflozin on biomarkers of heart failure in patients with myocardial infarction with and without type 2 diabetes mellitus within 6 months after the event.;Secondary Objective: To investigate - Short term changes of nt-proBNP levels - Short term and intermediate term changes in echocardiography parameters - Change in levels of ketone body concentrations - Change in HbA1c levels - Change in body weight - Number of hospital re-admissions due to heart failure or other causes - Duration of hospital stay - All-cause mortality ;Primary end point(s): Difference in the change of nt-proBNP levels between treatment groups from randomization to week 26;Timepoint(s) of evaluation of this end point: Baseline and week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in the change of EF between treatment groups from randomization to week 26 -Difference in the change of EF between treatment groups from randomization to week 6 -Difference in the change of left ventricular diastolic function from randomization to week 26 -Difference in the change of left ventricular diastolic function from randomization to week 6 -Difference in the change of nt-proBNP levels between treatment groups from randomization to week 6 -Difference in the change of HbA1c between treatment groups from randomization to week 26 (in subjects with known T2DM) -Difference in the change of body weight between treatment groups from randomization to week 6 -Difference in the change of body weight between treatment groups from randomization to week 26 -Difference in the change of blood beta-hydroxybutyrate levels between the treatment groups from randomization to week 6 -Difference in the change of blood beta-hydroxybutyrate levels between the treatment groups from randomization to week 26 -Difference in the number of hospital re-admissions due to heart failure between the treatment groups -Difference in the number of hospital re-admissions for any cause between the treatment groups -Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment ;Timepoint(s) of evaluation of this end point: baseline, week 6 and week 26 | — |
Countries
Austria
Contacts
Public ContactHarald Sourij
Medical University of Graz
Outcome results
None listed