Efficacy and Safety of Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .
研究概览
简要总结
As one of the most common chronic diseases,The adult prevalence of hypertension is approximately 26.4% at present and will rise to 29.2% by 2025.Renal sympathetic denervation from the intima of renal artery has emerged as a potential treatment for resistant hypertension. However, renal sympathetic nerve are mainly located in the adventitia,and there is no report on renal sympathetic denervation from the adventitia of renal artery.This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.
详细描述
This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 years old ≤ age ≤ 65 years old; 2.Patients with clear diagnosis of resistant hypertension prior to enrollment：On the basis of improving lifestyle, a reasonable and tolerable amount of 3 or more kinds of antihypertensive drugs (including diuretics) for more than one month, clinic SBP≥140mmHg or (and) DBP≥90mmHg, 24 hours dynamic Blood pressure monitoring SBP>130mmHg or (and) DBP>80mmHg; 3.Estimated GFR (eGFR) ≥ 60ml/min/1.73m2; 4.The patient or his legal guardian has signed the informed consent; 5.Patients who are willing and able to perform follow-up visits.
排除标准
- •Patients with secondary hypertension caused by any known cause;
- •pregnant or planning to be pregnant;
- •Patients with renal artery diameter <4mm or length <20mm;
- •Patients with renal artery abnormalities include: hemodynamic or anatomically significant stenosis (≥50%) of renal arteries on either side;renal arterial balloon angioplasty or stenting;renal involvement on either side Multiple renal arteries,and renal arteries supply <75% of the kidneys;abnormal renal artery anatomy,such as tumor expansion;
- •Patients with cardiovascular instability factors includes:acute myocardial infarction within six months,unstable angina or cerebrovascular disease;heart valve disease with significantly altered hemodynamics;
- •Patients with other serious organic diseases;
- •Patients participated in other studies.
结局指标
主要结局
Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .
时间窗: Baseline to 6 months
次要结局
- Change in 24-hour average diastolic blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 6 months after discharge(Baseline to 6 months)
- Change in 24-hour average blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 1,3,12 months after discharge(Baseline to 1 months,3 months,12 months)
- Change in systolic/diastolic blood pressure by home blood pressure monitoring in 1,3,6,12 months after discharge(Baseline to 1 months,3 months,6 months,12 months)
- Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge.(Baseline to 1 months,3 months,6 months,12 months)
- renal function in 1,3,6,12 months after discharge(Baseline to 1 months,3 months,6 months,12 months)
- Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge(Baseline to 1 months,3 months,6 months,12 months)
- The surgical complications of renal artery perforation,such as stenosis,and dissection associated with radiofrequency surgery.And major cardiovascular and cerebrovascular events ,including cardiac death,stroke and nonfatal- myocardial infarction.(Baseline to 6 months,12 months)