Renal Sympathetic Modification in Patients With Essential Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- composite cardiovascular events
研究概览
简要总结
The purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with essential hypertension, and evaluate safety and efficacy of the intervention.
详细描述
Hypertension is a common cardiovascular disease, and is also an important risk factor for heart-brain-renal diseases, with relatively low controlled rate. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that sympathetic nerves activity contributed to development and perpetuation of hypertension. Renal ablation for sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of hypertension. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary anti-hypertensive medications besides expectant intervention, and patients in control group will receive appropriate anti-hypertensive medications only. We aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with hypertension, and evaluate safety and efficacy of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •≥ 18 years old, and ≤ 75 years old of age
- •more than half a year history of hypertension, except for valvular heart disease
- •recently at least three times office blood pressure suggest systolic blood pressure of 140mmHg or more and/or a diastolic blood pressure of 90mmHg or more
- •estimated glomerular filtration rate (eGFR) of ≥ 45mL/min
- •is competent and willing to provide written, informed consent to participate in this clinical study
排除标准
- •secondary hypertension
- •isolated systolic hypertension
- •estimated glomerular filtration rate (eGFR) of < 45mL/min
- •has the history of renal restenosis or renal stents implantation
- •has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
- •patients with sick sinus syndrome
- •pregnant women
- •mental disorders
- •patients that have allergy to contrast agent
- •patients that do not go with follow-up
- •others such as researcher considers it is not appropriate to be included into the study
研究组 & 干预措施
renal sympathetic modification
Renal artery ablation to modify sympathetic activity in patients with essential hypertension.
干预措施: renal sympathetic modification (Procedure)
Absolute medicine therapy
Maintenance of anti-hypertensive medications only
结局指标
主要结局
composite cardiovascular events
时间窗: three years
Comprising myocardial infarction, stroke, heart failure, sudden death
次要结局
未报告次要终点
研究者
Yuehui Yin
Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center
The Second Affiliated Hospital of Chongqing Medical University