NCT01865253终止4 期
Renal Denervation for Complicated Hypertension (RDNP-2012-03)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in average office blood pressure
研究概览
简要总结
This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:
- intolerance to antihypertensive medication
- inability to take antihypertensive medication due to planned pregnancy
- renal artery stenosis
- chronic kidney disease
- non-compliance to antihypertensive medication
A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.
The duration of this study is 36 months.
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 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)
- •Intolerance to ≥2 antihypertensive drug classes
- •Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
- •Renal artery stenosis
- •Chronic Kidney Disease
排除标准
- •renal artery anatomy ineligible for treatment
- •individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
- •female participants of childbearing potential must have negative pregnancy test prior to treatment
研究组 & 干预措施
Renal Denervation
Experimental
Renal Denervation treatment
干预措施: Renal Denervation (Device)
结局指标
主要结局
Change in average office blood pressure
时间窗: baseline to 6 months post procedure
Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure
次要结局
- Change in Quality of life(baseline to 6 months post procedure)
- Blood pressure control(baseline to 6 months post procedure)
- Time to achieve blood pressure target(baseline to 6 months post procedure)
- Change in sympathetic nerve activity(baseline to 6 months post procedure)
- Change in left ventricular structure and function(baseline to 6 months post procedure)
- Number of drugs required to reach target blood pressure(baseline to 6 months post procedure)
- Change in serum and urine Biochemistry(baseline to 6 months post procedure)
- Change in markers of arterial stiffness(baseline to 6 months)
研究者
研究点 (2)
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