Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension (RSD4CKD)
2012年11月30日 更新者：Qijun Shan、The First Affiliated Hospital with Nanjing Medical University
Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertension
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Jiangsu
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Nanjing、Jiangsu、中国、210000
- 招聘中
- First Affiliated Hospital of Nanjing Medical University
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接触：
- Shan Qi Jun, Professor
- 电话号码：0086 025 68136407
- 邮箱：qjshan@njmu.edu.cn
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首席研究员：
- Shan Qi Jun, Professor
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首席研究员：
- Xing Ch Ying, Professor
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首席研究员：
- Chen Chun, Professor
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副研究员：
- Zhou X Juan, Professor
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副研究员：
- Qian W Chong, Professor
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副研究员：
- Liu Jia, Professor
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副研究员：
- Yu X Bao, Professor
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副研究员：
- Mao H Juan, Professor
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副研究员：
- Yao Jing, Doctor
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副研究员：
- Xu X Qiang, Doctor
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副研究员：
- Wang X Mei, Nurse
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副研究员：
- Duan X Yan, Master
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副研究员：
- Qiu Min, Master
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副研究员：
- Geng Jie, Master
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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).
|
Contrast renal angiography(iodixanol) was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD.
Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery.
then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis.
About six to nine ablations at 10 W for 1 min each were performed in both renal arteries.
During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
其他名称：
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安慰剂比较：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).
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Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
大体时间：36 months
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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.
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36 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Urinary protein excretion and renal function
大体时间：36 months
|
To evaluation of urinary protein excretion and renal function over time, by the reciprocal of the serum and urinary creatinine level, creatinine clearance and the glomerular filtration rate.
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36 months
|
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Blood pressure
大体时间：36 months
|
To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension, which can be measured by ambulatory blood pressure and home blood pressure monitoring.
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36 months
|
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Blood sugar
大体时间：36 months
|
In order to study whether RSD can reduce the blood sugar level and insulin resistance of diabetic patients.
It will be measured by fasting blood glucose, glycated hemoglobin, fasting insulin .
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36 months
|
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Cardiac function and structure
大体时间：36 months
|
The effect of renal sympathetic denervation(RSD) on cardiac function and structure can be measured by echocardiographic(include the degree of cardiac pachynesis, left ventricular ejection fraction，left ventricular end diastolic diameter, ventricular septal thickness and so on).
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36 months
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Arrhythmia
大体时间：36 months
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If a new arrhythmia is discovered during the follow-up, it will be recorded.
Patients may have symptoms of flustered, palpitations, dizziness, amaurosis, syncope and so on, which can be diagnosed by ECG and Holter.
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36 months
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Pulse wave velocity
大体时间：36 months
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So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
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36 months
|
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Life quality
大体时间：36 months
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Life quality on 36-item short-form(SF-36),HRQoL and PRODISQ Health Survey Questionnaire will be carried out during the follow-up to study the patients' life quality.
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36 months
|
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Rehospitalization rate
大体时间：36 months
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To study whether RSD can reduce the patients' rehospitalization rate, which will be measured by questionnaire and telephone follow-ups.
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36 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dialysis
大体时间：36 months
|
In order to study the effect of renal sympathetic denervation on renal function in patients with dialysis, which can be measured by the proportion of patients who do not need dialysis anymore.
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36 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Shan Qi Jun, professor、The First Affiliated Hospital with Nanjing Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年11月1日
初级完成 (预期的)
2017年8月1日
研究完成 (预期的)
2018年4月1日
研究注册日期
首次提交
2012年11月27日
首先提交符合 QC 标准的
2012年11月27日
首次发布 (估计)
2012年11月29日
研究记录更新
最后更新发布 (估计)
2012年12月3日
上次提交的符合 QC 标准的更新
2012年11月30日
最后验证
2012年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.