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Renal Sympathetic Modification in Patients With Chronic Renal Failure

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ClinicalTrials.gov Identifier: NCT01418560
Recruitment Status : Recruiting
First Posted : August 17, 2011
Last Update Posted : July 17, 2017
Sponsor:
Collaborators:
Jiangsu Provincial People's Hospital
Chongqing Medical University
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University

August 15, 2011
August 17, 2011
July 17, 2017
August 2011
June 2019   (Final data collection date for primary outcome measure)
the incident of uremia and dialysis requirement [ Time Frame: three years ]
Same as current
Complete list of historical versions of study NCT01418560 on ClinicalTrials.gov Archive Site
  • serum creatinine increases into multiples in 1 month follow-up [ Time Frame: three years ]
  • effect of urine microalbumin, urine microalbumin/creatinine, serum creatinine, or 24 hrs urine protein value [ Time Frame: three years ]
  • incidence of composite cardiovascular events [ Time Frame: three years ]
Same as current
Not Provided
Not Provided
 
Renal Sympathetic Modification in Patients With Chronic Renal Failure
Renal Sympathetic Modification in Patients With Chronic Renal Failure
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.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Renal Failure
Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation
  • Experimental: renal sympathetic modification
    Renal artery ablation to modify sympathetic activity in patients with chronic renal failure.
    Intervention: Procedure: renal sympathetic modification
  • No Intervention: Absolute medicine therapy
    Maintenance of anti-renal failure medications only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Same as current
June 2020
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact: Yuehui Yin, MD 0086-13508335502 yinyh63@163.com
China
 
 
NCT01418560
SWAN-RF
Yes
Not Provided
Not Provided
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
  • Jiangsu Provincial People's Hospital
  • Chongqing Medical University
Not Provided
The Second Affiliated Hospital of Chongqing Medical University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP