Renal Sympathetic Modification in Patients With Chronic Renal Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University
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
ClinicalTrials.gov Identifier:
NCT01418560
First received: August 15, 2011
Last updated: May 2, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


Further study details as provided by The Second Affiliated Hospital of Chongqing Medical University:

Primary Outcome Measures:
  • the incident of uremia and dialysis requirement [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418560

Contacts
Contact: Yuehui Yin, MD 0086-13508335502 yinyh63@163.com

Locations
China, Chongqing
2ndChongqingMU Recruiting
Chongqing, Chongqing, China, 400010
Contact: Yuehui Yin, MD    0086-23-63693766    yinyh63@163.com   
Principal Investigator: Yuehui Yin, MD         
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Jiangsu Provincial People's Hospital
Chongqing Medical University
  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:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 18, 2014