Renal Denervation for Uncontrolled Hypertension (RDNP-2012-02)
研究概览
详细说明
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.
研究类型
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
- concurrent treatment with 2 anti-hypertensive drugs
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：去肾神经组
参与者随机接受去肾神经手术
|
去肾神经导管
其他名称：
|
|
无干预：日常护理
随机分配到常规护理组的参与者将接受额外的抗高血压药物治疗以达到血压目标
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
blood pressure control
大体时间：6 months post procedure
|
percentage of patients who achieve BP target at 6 months post intervention
|
6 months post procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
达到血压目标的时间
大体时间：基线至 6 个月
|
达到血压目标的时间
|
基线至 6 个月
|
|
number of drugs required to reach target blood pressure
大体时间：baseline to 6 months
|
number of drugs required to reach target blood pressure
|
baseline to 6 months
|
|
change in sympathetic nerve activity
大体时间：baseline to 6 months
|
changes in muscle sympathetic nerve activity (MSNA), renal and whole body Noradrenaline (NA) spillover
|
baseline to 6 months
|
|
Change in left ventricular function
大体时间：baseline to 6 months
|
Change in left Ventricular ejection fraction, diastolic filling
|
baseline to 6 months
|
|
Change in Quality of Life
大体时间：baseline to 6 months
|
Change in Quality of life as assessed be relevant questionnaires
|
baseline to 6 months
|
|
Change in Serum Biochemistry
大体时间：baseline to 6 months
|
Plasma Renin Activity, aldosterone levels, estimated Glomerular Filtration Rate(eGFR), inflammatory markers, fasting glucose, fasting insulin, C-peptide, Homeostasis Model Assessment (HOMA) index, Lipid profile
|
baseline to 6 months
|
|
Change in markers of arterial stiffness
大体时间：baseline to 6 months
|
Change in markers of arterial stiffness as assessed by Augmentation Index (AI) and Pulse Wave Velocity (PWV)
|
baseline to 6 months
|
|
Change in left ventricular structure
大体时间：baseline to 6 months
|
Change in left ventricular mass index
|
baseline to 6 months
|
|
Change in Urine Biochemistry
大体时间：baseline to 6 months
|
Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium
|
baseline to 6 months
|
合作者和调查者
调查人员
- 首席研究员：Markus P Schlaich, MD、Baker IDI Heart & Diabetes Institute
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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