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Full Length Versus Proximal Renal Arteries Ablation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01848275
First Posted: May 7, 2013
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation

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

Primary Outcome Measures:
  • Blood pressure [ Time Frame: one year ]
    office BP and Ambulatory blood pressure


Secondary Outcome Measures:
  • ablation-related complications [ Time Frame: one year ]
    ablation-related complications such as pseudoaneurysm,renal artery injury


Enrollment: 47
Actual Study Start Date: March 2011
Study Completion Date: June 2015
Primary Completion Date: December 2014 (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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848275


Locations
China, Chongqing
2ndChongqingMU
Chongqing, Chongqing, China, 400010
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
  More Information

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
First Submitted: May 3, 2013
First Posted: May 7, 2013
Last Update Posted: July 17, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Coronary Vasospasm
Hypertension
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases