Clinical trial NCT01418560: Renal Sympathetic Modification in Patients With Chronic Renal Failure
Official title: Renal Sympathetic Modification in Patients With Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Renal Failure
Keywords: renal artery
sympathetic nerves
modification
chronic renal failure
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu Provincial People's Hospital
name: Chongqing Medical University
First posted: 2011-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: the incident of uremia and dialysis requirement
timeFrame: three years
Secondary outcomes:
measure: serum creatinine increases into multiples in 1 month follow-up
timeFrame: three years
measure: effect of urine microalbumin, urine microalbumin/creatinine, serum creatinine, or 24 hrs urine protein value
timeFrame: three years
measure: incidence of composite cardiovascular events
timeFrame: three years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: 2ndChongqingMU
state: Chongqing
Study officials:
References: