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临床试验/NCT00753116
NCT00753116已完成1 期

Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Medtronic Vascular2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.

研究概览

简要总结

The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

入选标准

  • Systolic blood pressure of 160 mmHg or greater
  • On 3 or more antihypertensive medications
  • On dialysis for more than 6 months

排除标准

  • Renal artery abnormalities
  • Known secondary hypertension attributable to a cause other than sleep apnea
  • MI, angina, CVA within 6 months

结局指标

主要结局

Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.

时间窗: Through 1 year

次要结局

  • Physiologic response to denervation (e.g., blood pressure reduction)(Through 1 year)

研究者

发起方
Medtronic Vascular
申办方类型
Industry

研究点 (2)

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