Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
研究概览
简要总结
To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertension
详细描述
Chronic kidney disease(CKD) is a global and growing public health problem, and its frequency increases with age. The major complications of CKD involve losing renal function and cardiovascular disease, which result in significant morbidity, mortality, and cost. The main measures for treatment of CKD are optimizing drug therapy and renal replacement therapy. Optimizing drug therapy, including vascular angiotensin-converting enzyme inhibitors, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on. However, the situation for treatment of CKD is not satisfying. Sympathetic overactivity plays a key role in the development and progression of CKD. Sympathetic nerve activity was increased in patients with all stages of CKD, which was associated with cardiovascular events and all-cause mortality. At the same time, hypertension and proteinuria become the most important risk factor for progression of CKD. Recently, many clinical researches have verified that Catheter-based renal sympathetic denervation can safely be used to substantially reduce muscle and whole-body sympathetic-nerve activity (MSNA) and whole-body norepinephrine spillover. Simultaneously, a marked reduction in blood pressure, sleep apnea severity and urine micro albumin level is apparent, with a improvement glucose tolerance. Sympathetic activation, high norepinephrine level, hypertension, glucose tolerance abnormity, proteinuria and obstructive sleep apnea are all recognized as independent risk factors for the development and progression of CKD. So, we design this randomized parallel control clinical study to demonstrate whether RSD can slow the progression of CKD and reduce the rate of all-cause mortality effectively and securely.
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 (Outcomes Assessor)
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
- •Subject is ≥ 18 and ≤75 years of age.
- •A serum creatinine level of 1.5 to 5.0 mg per deciliter (133 to 442 μmol per liter), a creatinine clearance of 20 to 70 ml per minute per 1.73 m2, with variations of less than 30 percent in the three months before randomization.
- •Persistent proteinuria (defined by urinary protein excretion of more than 0.3 g per day for three or more months which can evacuate urinary tract infection and overt heart failure [a New York Heart Association class of III or IV]).
- •Resistant hypertension.
- •Nondiabetic renal disease.
- •Subject is willing and able to comply with the protocol
- •Subject is expected to remain available for follow-up visits at the study center
- •Subject Informed Consent.
排除标准
- •Current treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive drugs.
- •Connective-tissue disease.
- •Obstructive uropathy.
- •Congestive heart failure (New York Heart Association class III or IV).
- •Subject has significant renovascular abnormalities (a history of prior renal artery intervention, including balloon angioplasty or stenting; double renal artery on one side, distortion, and extension ), measured by abdominal ultrasound or renal angiograms.
- •Subject has a history of myocardial infarction, unstable angina, cerebrovascular accident or alimentary tract hemorrhage in the previous 3 months.
- •Subject with sick sinus syndrome.
- •Subject has a history of allergy to contrast media; psychiatric disorders; drug or alcohol abuse; and pregnancy.
- •Enrolled in a concurrent study that may confound the results of this study
研究组 & 干预措施
RSD+Medicine
The investigators will recruit 50 randomised CKD patients who meet the inclusion criteria. First undergo renal artery angiography procedure to confirm anatomy. If renal artery meet the inclusion criteria, give the renal sympathetic denervation. At the same time, we will use optimal medication to protect renal function. Then we will conduct a clinic follow-up and a telephone follow-up e(Total 36 months).
干预措施: RSD (Procedure)
Medicine
The investigators aslo will recruit 50 randomised CKD patients who meet the inclusion criteria. There are no significant differences in age, gender, race, past medical history,personal history and so on between the two groups. In this group we will use optimal medication just like the RSD+Medicine group. Third we will conduct a clinic and a telephone follow-up(Total 36 months).
干预措施: medicine (Drug)
结局指标
主要结局
All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
时间窗: 36 months
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality,doubling of the serum creatinine level or end-stage renal disease in patients with chronic kidney disease and resistant hypertension.
次要结局
- Urinary protein excretion and renal function(36 months)
- Blood pressure(36 months)
- Blood sugar(36 months)
- Cardiac function and structure(36 months)
- Arrhythmia(36 months)
- Pulse wave velocity(36 months)
- Life quality(36 months)
- Rehospitalization rate(36 months)
研究者
Qijun Shan
Professor，Director, Cardiac Arrhythmia Group
The First Affiliated Hospital with Nanjing Medical University