Impact of Empagliflozin on heart in patients with myocardial infarctio

Phase 1

• Conditions: Myocardial infarction; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004591-22-AT
• Lead Sponsor: Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-07
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 476

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

1)Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
2)Blood pH < 7,32
3)Known allergy to SGLT-2 inhibitors
4)Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors
5)>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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>- Short term changes of nt-proBNP levels <br>- Short term and intermediate term changes in echocardiography parameters <br>- Change in levels of ketone body concentrations <br>- Change in HbA1c levels<br>- Change in body weight<br>- Number of hospital re-admissions due to heart failure or other causes<br>- Duration of hospital stay <br>- All-cause mortality<br>;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