Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction

• Status: Active, not recruiting
• Trial end date: 2022-04-02
• Target enrollment: 0
• Participant gender: All

Summary

This study is planned 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborators: Barmherzige Brüder Eisenstadt; Hospital Rudolfstiftung; Johannes Kepler University of Linz; Kardinal Schwarzenberg Klinikum Schwarzach St. Veit; Kepler University Hospital; Klinikum Klagenfurt am Wörthersee; Krankenhaus der Barmherzigen Brüder Linz; Landesklinikum Sankt Polten; Landeskrankenhaus Feldkirch; Landeskrankenhaus II Graz West; Medical University of Vienna; Paracelsus Medical University; United Arab Emirates University
• Treatments: Empagliflozin

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-level (or troponin I-level) >10x ULN (upper limit of normal). In addition at least 1 of the following criteria must be the met:

• Symptoms of ischemia

• ECG (electrocardiogram) 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 (glomerular filtration rate) > 45 ml/min/1.73m2

5. Blood pressure before first drug dosing: RR systolic >110 mmHg

6. Blood pressure before first drug dosing: RR diastolic >70 mmHg

7. ≤72h after myocardial infarction (after the performance of a coronary angiography)

Exclusion Criteria:

1. Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis

2. Blood pH (potential hydrogen) < 7,32

3. Known allergy to SGLT-2 inhibitors

4. Hemodynamic instability as defined by intravenous administration of catecholamine, calcium sensitizers or phosphodiesterase inhibitors

5. >1 episode of severe hypoglycemia within the last 6 months and treatment with insulin or sulfonylurea

6. Females of childbearing potential without adequate contraceptive methods (i.e. sterilization, intrauterine device, vasectomized 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 or having received treatment with any SGLT-2 inhibitor within the 4 weeks prior to the screening visit