ACTRN12622000978763招募中2 期
SGLT2 Inhibition with Empagliflozin on Metabolic, Cardiac and Renal Outcomes in Recent Cardiac Transplant Recipients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
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
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Sex: men and women
- •Age range: over 18 years old
- •Cardiac transplant recipients recruited within 6-8 weeks from the date of cardiac transplant
- •Free from major rejection at enrolment
- •Baseline eGFR >30 mL/min/1.73m2
- •Willingness to give written informed consent and willingness to participate to and comply with the study
排除标准
- •Exposure to an SGLT2 inhibitor within the last 30 days
- •Previous adverse event related to SGLT2 inhibitor use
- •History of diabetic ketoacidosis
- •History of urosepsis
- •Fasting beta hydroxybutyrate >1.7 mmol/L at baseline
- •Known major organ dysfunction (eGFR < 30 mL/min/1.73m2, liver disease transaminases > 5 times the upper limit of normal, current cancer or uncontrolled thyroid dysfunction). These conditions either interfere with the excretion or metabolism of the test medication, or would interfere with measurement of the study outcome.
- •Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study
研究者
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