Back to resultsFull Length Versus Proximal Renal Arteries Ablation
Primary Purpose
Hypertension, Resistant to Conventional Therapy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thermocool®Rcatheter
Thermocool®Rcatheter
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Resistant to Conventional Therapy
Eligibility 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)
Sites / Locations
- 2ndChongqingMU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1
Group 2
Arm Description
Group 1 received ablation from distal to ostial of bilateral renal arteries
group 2 received ablation at proximal of bilateral renal arteries
Outcomes
Primary Outcome Measures
Blood pressure
office BP and Ambulatory blood pressure
Secondary Outcome Measures
ablation-related complications
ablation-related complications such as pseudoaneurysm，renal artery injury
Full Information
NCT ID
NCT01848275
First Posted
May 3, 2013
Last Updated
July 13, 2017
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01848275
Brief Title
Full Length Versus Proximal Renal Arteries Ablation
Official Title
The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Resistant to Conventional Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Group 1 received ablation from distal to ostial of bilateral renal arteries
Arm Title
Group 2
Arm Type
Experimental
Arm Description
group 2 received ablation at proximal of bilateral renal arteries
Intervention Type
Device
Intervention Name(s)
Thermocool®Rcatheter
Intervention Description
The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter
Intervention Type
Device
Intervention Name(s)
Thermocool®Rcatheter
Intervention Description
The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter
Primary Outcome Measure Information:
Title
Blood pressure
Description
office BP and Ambulatory blood pressure
Time Frame
one year
Secondary Outcome Measure Information:
Title
ablation-related complications
Description
ablation-related complications such as pseudoaneurysm，renal artery injury
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
2ndChongqingMU
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
12. IPD Sharing Statement
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Full Length Versus Proximal Renal Arteries Ablation
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