Renal Denervation for Uncontrolled Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- blood pressure control
研究概览
简要总结
This is a study investigating the safety and usefulness of the Renal Denervation Procedure in reducing high blood pressure in people whose blood pressure is not adequately controlled despite already being treated with 2 blood pressure lowering drugs. This study is designed to compare the effects renal denervation to a usual care group.
详细描述
This is a phase 4 randomised control trial of renal denervation for the treatment of uncontrolled hypertension.
Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure.
A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets.
The duration of this study is 36 months.
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
- 否
入选标准
- •BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
- •concurrent treatment with 2 anti-hypertensive drugs
排除标准
- •renal artery anatomy ineligible for treatment
- •eGFR <15mL/min/1.73m2 (using MDRD formula)
- •individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
- •female participants of child bearing potential must have negative pregnancy test prior to treatment
结局指标
主要结局
blood pressure control
时间窗: 6 months post procedure
percentage of patients who achieve BP target at 6 months post intervention
次要结局
- Change in Urine Biochemistry(baseline to 6 months)
- number of drugs required to reach target blood pressure(baseline to 6 months)
- Change in left ventricular function(baseline to 6 months)
- Change in Quality of Life(baseline to 6 months)
- time to achieve blood pressure target(baseline to 6 months)
- Change in markers of arterial stiffness(baseline to 6 months)
- Change in left ventricular structure(baseline to 6 months)
- change in sympathetic nerve activity(baseline to 6 months)
- Change in Serum Biochemistry(baseline to 6 months)