NCT02630355终止2 期
Randomized Controlled Trial of Remote Ischaemic Preconditioning to Protect Against Dialysis Induced Cardiac Injury in Haemodialysis: Low Vs. High Intensity
Western University, Canada0 个研究点目标入组 32 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 主要终点
- The primary outcome will be a reduction in the number of left ventricular segments undergoing a greater than 30% reduction in longitudinal strain as detected by echocardiography at final study visit
研究概览
简要总结
This study evaluates the use of remote ischaemic preconditioning for the prevention of dialysis induced cardiac injury. The study uses four arms to test different frequencies of application to ascertain which, if any, is most successful at reducing dialysis induced cardiac injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
- •Male and female, age≥16 years old.
排除标准
- •Not meeting inclusion criteria
- •Exposure to haemodialysis for <90 days prior to recruitment
- •Severe heart failure (New York Heart Association grade IV)
- •Cardiac transplant recipients
- •Mental incapacity to consent
- •Declined to participate
- •Taking cyclosporin
- •Taking ATP-sensitive potassium channel opening or blocking drugs
结局指标
主要结局
The primary outcome will be a reduction in the number of left ventricular segments undergoing a greater than 30% reduction in longitudinal strain as detected by echocardiography at final study visit
时间窗: 4 weeks
次要结局
- Change in Troponin-T, Plasma IL-6 and N-Type proBNP at intervention, first follow-up and final visit(up to 4 weeks)
- Number of segments undergoing >30% reduction in longitudinal strain at intervention, week 1, week 2 and week 3 visits(up to 3 weeks)
- Difference between pre and peak global longitudinal strain at intervention, week 1, week 2 and week 3 visits(up to 3 weeks)
- Change in pre-dialysis global longitudinal strain between baseline and final study visit(between 1 and 4 weeks)
研究者
Christopher McIntyre
Dr.
Western University, Canada
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