Renal Denervation for Resistant Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- blood pressure control
研究概览
简要总结
This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.
详细描述
Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.
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
- •systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
- •concurrent treatment with ≥3 anti-hypertensive drugs
排除标准
- •renal artery anatomy ineligible for treatment
- •eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
- •female participants of childbearing potential must have negative pregnancy test prior to treatment
研究组 & 干预措施
Renal Denervation Group
participants randomised to undergo the renal denervation procedure
干预措施: Renal Denervation (Device)
Usual care
participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets
结局指标
主要结局
blood pressure control
时间窗: 6 months post procedure
percentage of patients to achieve Blood Pressure (BP) target (BP \<140/90mmHg, or \<130/80mmHg in diabetic patients) at 6 months post procedure
次要结局
- number of drugs required to reach blood pressure target(baseline to 6 months)
- Change in Left Ventricular Structure and Function(baseline to 6 months)
- Change in Quality of Life(baseline to 6 months)
- Serum and Urine Biochemistry(baseline to 6 months)
- Change in markers of arterial stiffness(baseline to 6 months)
- time to achieve blood pressure target(baseline to 6 months)
- Change in markers of sympathetic nerve activity(baseline to 6 months)