NCT01785732Unknown不适用
Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)
The Hospital District of Satakunta1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Office blood pressure
研究概览
简要总结
Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension.
The purpose of RENSYMPIS is to study the effects of renal denervation on:
- Cardiovascular function
- Metabolic factors
- Inflammatory and endocrine factors
- Coagulation
- Sleep
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
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resistant Hypertension (systolic blood pressure >160mmHg and 3 or more antihypertensive agents in use)
- •Age 30- 69 years
- •Written informed consent
排除标准
- •Secondary hypertension
- •Pseudohypertension
- •Pregnancy
- •Renal insufficiency (GFR <45ml/min)
- •Clinically significant stenotic valvular disease
- •Oral anticoagulation
- •CCS III-IV symptoms or CABG/PCI in previous 6 months
- •Prior stroke
- •Contrast agent allergy
- •inappropriate renal artery anatomy (< 4mm diameter, < 20mm length)
结局指标
主要结局
Office blood pressure
时间窗: 2 years
次要结局
- Ambulatory blood pressure(2 years)
- Insulin resistance(2 years)
- Endothelial function(2 years)
研究者
研究点 (1)
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