ACTRN12621000355875招募中4 期
Randomised trial of Empagliflozin and Left ventricular diastolic function in adults with Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 80 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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