Randomised trial of Empagliflozin and Left ventricular diastolic function in Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D)
- Conditions
- Diabetes mellitusAcute coronary syndromeCardiovascular - Coronary heart diseaseMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12621000355875
- Lead Sponsor
- Fiona Stanley Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
•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.
•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.
•Unable to perform supine bicycle stress echocardiography.
•Hypertension (systolic blood pressure >200 and/or diastolic blood pressure >110 mmHg).
•Inability to provide informed consent.
•Pregnant or breastfeeding women.
•Known hypersensitivity to empagliflozin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method