NCT00664638已完成不适用
Renal Denervation in Patients With Refractory Hypertension
Medtronic Vascular10 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2008年4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
- 45
- 试验地点
- 10
- 主要终点
- To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension.
研究概览
简要总结
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age
- •a systolic blood pressure of 160mmHg or more
- •receiving and adhering to full doses of at least three antihypertensive drugs
- •estimated glomerular filtration rate (eGFR) of ≥45mL/min
- •agrees to have the study procedure(s) performed and additional procedures and evaluations
- •is competent and willing to provide written, informed consent to participate in this clinical study
排除标准
- •hemodynamically or anatomically significant renal artery stenosis
- •has a history or prior renal artery angioplasty
- •has experienced MI, unstable angina pectoris, or CVA within 6 months
- •has hemodynamically significant valvular heart disease
- •has Type 1 diabetes
- •has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
- •requires respiratory support
- •is pregnant, nursing, or planning to be pregnant
- •has known, unresolved history of drug use or alcohol dependency.
- •is currently enrolled in another investigational drug or device trial.
结局指标
主要结局
To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension.
时间窗: 3 years
次要结局
- To document the physiologic effects of renal denervation in patients with refractory hypertension.(3 years)
研究者
研究点 (10)
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