NCT01656096已完成4 期
Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension
University of Leipzig2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2012年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in systolic blood pressure (ABPM mean value)
研究概览
简要总结
The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory hypertension: 3 or more antihypertensive agents of different classes (including a diuretic) at optimal dosage without change in the 4 weeks preceding randomization
- •Systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmHg (ABPM mean daytime values)
- •No change in blood pressure medication within 6 months after randomization
- •Age 18 to 75 years
- •Informed consent
排除标准
- •Blood pressure outside range mentioned above
- •Renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation
- •Estimated glomerular filtration rate <45 mL/min/1.73 m² (modification of diet in renal disease formula)
- •Unstable angina pectoris
- •Myocardial infarction within 6 months prior to randomization
- •Planned surgery or cardiovascular intervention within 6 months after randomization
- •Severe heart valve disease
- •Severe comorbidities with limited life expectancy
- •Pregnancy
- •Participation in another trial
结局指标
主要结局
Change in systolic blood pressure (ABPM mean value)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Steffen Desch, MD
Principal Investigator
University of Leipzig
研究点 (2)
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