Renal Sympathetic Modification in Patients With Chronic Renal Failure

NCT01418560 | Unknown DMC

• 1 other identifier: SWAN-RF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure

Keywords

renal artery; sympathetic nerves; modification; chronic renal failure

Outcome Measures

Primary Outcomes (1)

• the incident of uremia and dialysis requirement

  three years

Secondary Outcomes (3)

• 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

• incidence of composite cardiovascular events

  three years

Study Arms (2)

renal sympathetic modification

EXPERIMENTAL

Renal artery ablation to modify sympathetic activity in patients with chronic renal failure.

Procedure: renal sympathetic modification

Absolute medicine therapy

NO INTERVENTION

Maintenance of anti-renal failure medications only

Interventions

renal sympathetic modification PROCEDURE

Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure

Also known as: renal denervation

renal sympathetic modification

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• Jiangsu Provincial People's Hospital: collaborator
• Chongqing Medical University: collaborator

Study Sites (1)

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuehui Yin, MD

CONTACT

0086-13508335502; yinyh63@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 17, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

CN (1)