ACTRN12621000355875
Recruiting
Phase 4
Randomised trial of Empagliflozin and Left ventricular diastolic function in adults with Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fiona Stanley Hospital
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes already on metformin and/or sulfonylurea therapy unless contraindicated.
- •Admission to hospital for ACS, defined as ST\-segment myocardial infarction, non\-ST\-segment elevation myocardial infarction or unstable angina, and undergoing coronary.
Exclusion Criteria
- •History of diabetic ketoacidosis.
- •Baseline HbA1c \<7% or \>10%.
- •Current SGLT2 inhibitor or glucagon\-like peptide\-1 agonist use or prior use within the last 6 months.
- •Atrial fibrillation or other serious cardiac arrhythmias (ventricular tachycardia, ventricular fibrillation or complete heart block).
- •Moderate or severe valvular heart disease or previous valve surgery.
- •Renal impairment with an estimated glomerular filtration rate of \<45 ml/min/1\.73m2\.
- •Hospital re\-admission for a cardiac\-related event during the trial, such as myocardial infarction, arrhythmia, heart failure, myocarditis, endocarditis, pericarditis or cardiac procedure/surgery.
- •Unstable ACS.
- •Active foot ulcer or gangrene.
- •Planned coronary intervention or bypass grafting during time of follow\-up.
Outcomes
Primary Outcomes
Not specified
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