跳至主要内容
临床试验/NCT05818813
NCT05818813招募中不适用

The Long-term Safety and Effect of Renal Denervation for Resistant Hypertension

Imperial College Healthcare NHS Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Change in systolic blood pressure

研究概览

简要总结

The goal of this observational study is to learn about the effects of renal denervation in patients with resistant hypertension. The main question it aims to answer is: What are the long term effects of renal denervation on blood pressure and flow within the arteries? Participants will undergo an assessment of their blood pressure, echocardiogram and invasive measurements of blood pressure and flow in the aorta and renal arteries before undergoing the renal denervation procedure. 6 months later these assessments will be repeated.

详细描述

Renal denervation is emerging as a succesful technique in the treatment of high blood pressure particularly for those people who's disease is resistant to drug therapy. It involves insertion of an catheter through the femoral artery and into the renal artery where it delivers a controlled radiofrequency ablation to the renal artery wall.

The purpose of this ablation is to interupt the sympathetic nervous system which is inappropriately activated in hypertension. Its beneficial effects on BP reduction has been borne out in a recently published randomised clinical trial which demonstrated a reduction in blood pressure in patients who underwent denervation compared to those managed with medication alone and it is now being used worldwide to manage hypertensive patients.

The safety of this procedure has been demonstrated in the peri-operative setting and short term particularly regarding anatomical changes and kidney function. However, its effects have not been demonstrated with invasive imaging or physiological testing in the long term. Therefore, the investigators recognise that a repeat assessment 6 months after denervation using invasive measures (to perform detailed assessments of the effects on aortic, flow and artery stiffness) would be of great benefit in stratifying this technique, which is likely to become widespread in the very near future.

The investigators therefore plan to perform denervation in 20 patients and obtain detailed information on kidney and aortic blood pressure and flow. They will then reassess these parameters after 6 months in the same patients to ensure preservation of pressure, flow and energy transfer and document the effects of denervation on vascular stiffness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 >160mmHg despite 3 antihypertensive agents
  • eGFR >45

排除标准

  • Secondary causes of hypertension
  • Prior renal artery intervention
  • Renal insufficiency
  • Significant stenotic valvular heart disease
  • Myocardial infarction, unstable angina or stroke within the preceding 6 months

结局指标

主要结局

Change in systolic blood pressure

时间窗: At baseline and at 6 months

Invasively measured aortic systolic pressure

次要结局

  • Change in diastolic pressure(At baseline and 6 months)
  • Change in renal artery flow(At baseline and 6 months)
  • Change in aortic wavespeed(At baseline and 6 months)
  • Change in left ventricular wall thickness(At baseline and 6 months)
  • Change in renal artery pressure(At baseline and 6 months)
  • Change in aortic reservoir pressure(At baseline and 6 months)
  • Change in renal artery resistance(At baseline and 6 months)
  • Change in aortic reservoir wave intensity(At baseline and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验