Renal Sympathetic Modification in Patients With Chronic Renal Failure
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Renal Failure |
Procedure: renal sympathetic modification |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Renal Sympathetic Modification in Patients With Chronic Renal Failure |
- the incident of uremia and dialysis requirement [ Time Frame: three years ] [ Designated as safety issue: Yes ]
- serum creatinine increases into multiples in 1 month follow-up [ Time Frame: three years ] [ Designated as safety issue: Yes ]
- effect of urine microalbumin, urine microalbumin/creatinine, serum creatinine, or 24 hrs urine protein value [ Time Frame: three years ] [ Designated as safety issue: Yes ]
- incidence of composite cardiovascular events [ Time Frame: three years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: renal sympathetic modification
Renal artery ablation to modify sympathetic activity in patients with chronic renal failure.
|
Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation
|
|
No Intervention: Absolute medicine therapy
Maintenance of anti-renal failure medications only
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Yuehui Yin, MD | 0086-13508335502 | yinyh63@163.com |
| China, Chongqing | |
| 2ndChongqingMU | Recruiting |
| Chongqing, Chongqing, China, 400010 | |
| Contact: Yuehui Yin, MD 0086-23-63693766 yinyh63@163.com | |
| Principal Investigator: Yuehui Yin, MD | |
More Information
No publications provided
| Responsible Party: | 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 |
| ClinicalTrials.gov Identifier: | NCT01418560 History of Changes |
| Other Study ID Numbers: | SWAN-RF |
| Study First Received: | August 15, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | China: Clinical Pharmacological Base of 2ndChongqingMU |
Keywords provided by The Second Affiliated Hospital of Chongqing Medical University:
|
renal artery sympathetic nerves modification chronic renal failure |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013