Full Length Versus Proximal Renal Arteries Ablation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University
Sponsor:
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01848275
First received: May 3, 2013
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.


Condition Intervention
Hypertension, Resistant to Conventional Therapy
Device: Thermocool®Rcatheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Blood pressure [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    office BP and Ambulatory blood pressure


Secondary Outcome Measures:
  • ablation-related complications [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    ablation-related complications such as pseudoaneurysm,renal artery injury


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Group 1 received ablation from distal to ostial of bilateral renal arteries
Device: Thermocool®Rcatheter
The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter
Experimental: Group 2
group 2 received ablation at proximal of bilateral renal arteries
Device: Thermocool®Rcatheter
The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter

Detailed Description:

After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • office systolic blood pressure of 160 mm Hg or more,
  • patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment.
  • Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications;
  • ≥ 18 years old,;
  • did not have any known secondary cause of hypertension;
  • had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more.

Exclusion Criteria:

  • patients with type 1 diabetes,
  • implanted pacemakers or implantable cardioverter defibrillators;
  • pregnant women;
  • haemodynamically significant valvular disease;
  • patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)
  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: NCT01848275

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

Locations
China, Chongqing
2ndChongqingMU Recruiting
Chongqing, Chongqing, China, 400010
Contact: Yuehui Yin, MD    0086-13508335502    yinyh63@163.com   
Sponsors and Collaborators
The Second Affiliated Hospital of 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: NCT01848275     History of Changes
Other Study ID Numbers: SWAN- RDN Strategy
Study First Received: May 3, 2013
Last Updated: May 6, 2013
Health Authority: China: Ethics Committee of 2ndChongqingMU

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014