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| Name | Class |
|---|---|
| Jiangsu Provincial People's Hospital | OTHER |
| Chongqing Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| renal sympathetic modification | Experimental | Renal artery ablation to modify sympathetic activity in patients with chronic renal failure. |
|
| Absolute medicine therapy | No Intervention | Maintenance of anti-renal failure medications only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| renal sympathetic modification | Procedure | Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incident of uremia and dialysis requirement | three years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuehui Yin, MD | Contact | 0086-13508335502 | yinyh63@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2ndChongqingMU | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
| incidence of composite cardiovascular events | three years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |