EUCTR2016-004591-22-AT
Active, not recruiting
Phase 1
Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY-Trial) – a phase III Study - EMMY-Trial
Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology0 sites476 target enrollmentFebruary 7, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myocardial infarction
- Sponsor
- Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology
- Enrollment
- 476
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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