NCT00888433已完成不适用
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Medtronic Vascular20 个研究点 分布在 10 个国家目标入组 106 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 20
- 主要终点
- Office Systolic Blood Pressure Reduction
研究概览
简要总结
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
- •on 3 or more antihypertensive medications
- •>= 18 and =< 85 years of age.
排除标准
- •renal artery abnormalities
- •eGFR < 45mL/min
- •MI, angina, CVA within 6 months
- •Type 1 diabetes
- •ICD or pacemaker, or any other metallic implant not compatible with MRI
结局指标
主要结局
Office Systolic Blood Pressure Reduction
时间窗: Baseline to 6 months
The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
次要结局
未报告次要终点
研究者
研究点 (20)
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