跳至主要内容
临床试验/NCT02021019
NCT02021019已完成不适用

Renal Denervation to Improve Outcomes in Patients With End-stage Renal

Baker Heart and Diabetes Institute2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Blood Pressure change

研究概览

简要总结

Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • end stage renal disease
  • hypertension (BP≥140/90mmHg)

排除标准

  • Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist.
  • Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.

结局指标

主要结局

Blood Pressure change

时间窗: 6 months

Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验