Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 主要终点
- Blood Pressure Reduction
研究概览
简要总结
The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.
详细描述
Prevalence of hypertension is increasing in China.While actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.Studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. Previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in Chinese patients. We hypothesis that renal denervation is effective and safe in treatment of Chinese patients with uncontrolled hypertension. This trial plan to recruit 100 patients(Ablation group VS Control group = 1:1) with a follow up duration of 3 years.Patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. We aim to explore the long term safety and validity of renal denervation in Chinese patients with uncontrolled hypertension.
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
- Single (Outcomes Assessor)
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 and/or a diastolic blood pressure of 90mmHg or more
- •receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
- •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
- •secondary hypertension
- •renal arterial abnormalities
- •has experienced MI, unstable angina pectoris, or CVA within 6 months
- •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
- •patients with sick sinus syndrome
- •pregnant woman
结局指标
主要结局
Blood Pressure Reduction
时间窗: one year
To confirm that renal denervation is safe, feasible and effective.
次要结局
未报告次要终点