ACTRN12609000174280已完成3 期
A randomised controlled trial of the beta-blocker carvedilol versus placebo to reduce cardiovascular morbidity and mortality in high-risk patients receiving dialysis: the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study
Australasian Kidney Trials Network- University of Queensland0 个研究点目标入组 150 人开始时间: 2009年4月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •1. The person has end-stage kidney disease and is receiving either haemodialysis or peritoneal dialysis 2. At the time of signing the consent form, the person is: i) Age >50 years, OR ii) Age >18 years with diabetes, OR iii) Age >18 years and has clinical features of cardiovascular disease (myocardial infarction or ischaemic heart disease, ischaemic stroke or peripheral arterial disease).
排除标准
- •1. Scheduled for live donor transplant within six months. 2. Experienced a cardiovascular event in the previous 3 months. Cardiovascular events include: myocardial infarction, admission for unstable angina, coronary revascularisation procedure, peripheral arterial revascularisation procedure or stroke. 3. Definite contra-indication to beta-blockers, such as: i) second or third degree atrioventricular block unless treated with a permanent pacemaker ii) sick sinus syndrome unless treated with a permanent pacemaker iii) clinically significant reversible bronchospasm iv) previous intolerance to beta-blockers v) other contra-indication 4. Currently taking a beta-blocker, verapamil, diltiazem or moxonidine and the treating nephrologist does not wish to stop these medications in order to enter the trial. 5. Considered by the treating nephrologist to be clinically or haemodynamically unstable for the study. 6. Unstable target weight (defined by a change of >2.0kg in target base weight over the preceding month). 7. Severe hepatic dysfunction (transaminases >3x higher than the upper normal limit) on the most recent liver function tests (if performed within 3 months). 8. Already involved in a clinical trial where the intervention being trialled is likely to confound the outcome of this trial. 9. Considered by the treating physician to have a life expectancy of less than 12 months. 10. Inability to provide consent or follow study instructions due to psychological illness or condition. 12. Pregnant or planning to be pregnant during the trial period.
研究者
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