Renal Sympathetic Modification in Patients With Chronic Renal Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the incident of uremia and dialysis requirement
研究概览
简要总结
The purpose of this study is to observe the incident of uremia and dialysis requirement after renal sympathetic modification using THERMOCOOL® catheter in patients with chronic renal failure, and evaluate safety and efficacy of the intervention.
详细描述
Chronic renal failure is serial clinical manifestations because of kidney damage. Previous studies found sympathetic nerves over activity in chronic renal failure patients. Traditional therapies included medications and dialysis replacement therapy need to spend much money. 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 chronic renal failure. 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 medications besides expectant intervention, and patients in control group will receive appropriate medications only. We aim to observe the effect of serum creatinine, creatinine clearance rate, glomerular filtration rate, urine microalbumin, urine microalbumin/creatinine, and composite cardio cerebrovascular events after renal sympathetic modification using THERMOCOOL® catheter, 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
- •at least three months history of definite kidney damage
- •renal function of serum creatinine of < 354umol/L, and/or creatinine clearance rate of ≥ 30ml/min, and/or estimated glomerular filtration rate of ≥ 45ml/min for recent 2-3 times evaluation. Besides, the value of creatinine clearance rate fluctuated no more than 30% in recent three months, and 15% in the following two weeks.
- •urine microalbumin, and/or urine microalbumin/creatinine is abnormal, and/or quantity of 24 hrs urine protein suggests kidney damage.
- •is competent and willing to provide written, informed consent to participate in this clinical study
排除标准
- •congenital renal diseases cause to chronic renal damage
- •estimated glomerular filtration rate (eGFR) of < 45mL/min
- •taking medicine of glucocorticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), or cytotoxic drugs at present
- •value of 24 hrs urine protein is of > 10g at least once in recent three months, or serum albumin of < 25g/L
- •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
- •carcinoma patients
- •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 chronic renal failure.
干预措施: renal sympathetic modification (Procedure)
Absolute medicine therapy
Maintenance of anti-renal failure medications only
结局指标
主要结局
the incident of uremia and dialysis requirement
时间窗: three years
次要结局
- serum creatinine increases into multiples in 1 month follow-up(three years)
- effect of urine microalbumin, urine microalbumin/creatinine, serum creatinine, or 24 hrs urine protein value(three years)
- incidence of composite cardiovascular events(three years)
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