Renal Sympathetic Modification in Patients With Heart Failure
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 heart failure, and evaluate safety and efficacy of the intervention.
详细描述
Heart failure is a clinical syndrome of chronic cardiac dysfunction, with high morbidity and mortality. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that partly blocking sympathetic nerves activity contributed to improve cardiac function in patients with heart failure. Renal ablation with sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. The investigators hypothesis that renal sympathetic nerves modification is effective and safe in improving cardiac function. 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-heart failure drugs besides expectant intervention, and patients in control group will receive appropriate anti-heart failure drugs only. The investigators aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.
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
- 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 heart failure, except for valvular heart disease
- •heart failure patients NYHA Class II III IV
- •left ventricular ejection function ≤ 40% or ≥ 45% (that is heart failure with preserved ejection fraction) with Simpson's method
- •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
- •patients with acute heart failure
- •patients with acute coronary syndrome
- •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 heart failure.
干预措施: renal sympathetic modification (Procedure)
Absolute medicine therapy
Maintenance of anti-heart failure medications only
结局指标
主要结局
composite cardiovascular events
时间窗: three years
Comprising myocardial infarction, heart failure, sudden death, cardiogenic 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