Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension (RSD4CKD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01737138|
Recruitment Status : Recruiting
First Posted : November 29, 2012
Last Update Posted : December 3, 2012
|Condition or disease||Intervention/treatment|
|Chronic Kidney Disease||Procedure: RSD Drug: medicine|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||April 2018|
Active Comparator: 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.
Placebo Comparator: 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).
Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on.
Other Name: drug
- All-cause mortality, doubling of the serum creatinine level or end-stage renal disease [ Time Frame: 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.
- Urinary protein excretion and renal function [ Time Frame: 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.
- Blood pressure [ Time Frame: 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.
- Blood sugar [ Time Frame: 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 .
- Cardiac function and structure [ Time Frame: 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).
- Arrhythmia [ Time Frame: 36 months ]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.
- Pulse wave velocity [ Time Frame: 36 months ]So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
- Life quality [ Time Frame: 36 months ]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.
- Rehospitalization rate [ Time Frame: 36 months ]To study whether RSD can reduce the patients' rehospitalization rate, which will be measured by questionnaire and telephone follow-ups.
- Dialysis [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737138
|Contact: Shan Qi jun, professor||0086 025 firstname.lastname@example.org|
|First Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: Shan Qi Jun, Professor 0086 025 68136407 email@example.com|
|Principal Investigator: Shan Qi Jun, Professor|
|Principal Investigator: Xing Ch Ying, Professor|
|Principal Investigator: Chen Chun, Professor|
|Sub-Investigator: Zhou X Juan, Professor|
|Sub-Investigator: Qian W Chong, Professor|
|Sub-Investigator: Liu Jia, Professor|
|Sub-Investigator: Yu X Bao, Professor|
|Sub-Investigator: Mao H Juan, Professor|
|Sub-Investigator: Yao Jing, Doctor|
|Sub-Investigator: Xu X Qiang, Doctor|
|Sub-Investigator: Wang X Mei, Nurse|
|Sub-Investigator: Duan X Yan, Master|
|Sub-Investigator: Qiu Min, Master|
|Sub-Investigator: Geng Jie, Master|
|Study Chair:||Shan Qi Jun, professor||The First Affiliated Hospital with Nanjing Medical University|