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临床试验/NCT01881035
NCT01881035终止不适用

Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
Comparison of blood pressures before and after intervention

研究概览

简要总结

The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.

详细描述

Drug resistant hypertension is very common in end stage renal disease treated by dialysis. The prevalence of hypertension has been evaluated to be over 50% and up 80%. In this patient group mortality figures are high because of cardiovascular diseases which are complications of hypertension. Renal nerve denervation is a new intervention to treat hypertension. By applying radiofrequency pulses to the renal arteries, the nerves in the vascular wall (adventitia layer) can be denervated. This causes reduction of renal sympathetic afferent and efferent activity and blood pressure can be decreased. The technique and its efficacy in end stage renal disease has not been systematically studied. There are case reports which have showed promising responses to denervation. In the present study 30 patients over 18 years are planned undergo renal denervation if the medical treatment (three different drugs including diuretics) has failed to decrease blood pressure sufficiently(160/100mmHg). The failure of medical treatment will be documented by ambulatory blood pressure measurements. After renal nerve denervation a two year follow-up of patients with ambulatory blood pressure measurements will be organized. The blood pressures before and after denervation are compared and the quality of life of the patients is evaluated by questionnaires.

研究设计

研究类型
Interventional
分配方式
Na
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

  • patients with end stage renal disease and drug-resistant blood pressure.

排除标准

  • pregnancy
  • secondary hypertension
  • unstable coronary artery disease

结局指标

主要结局

Comparison of blood pressures before and after intervention

时间窗: 2 years

次要结局

  • Quality of life(2 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Juhani Koistinen

Professor in Medicine Turku University

Turku University Hospital

研究点 (2)

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