Full Length Versus Proximal Renal Arteries Ablation

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:

The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848275
• Other study ID #: SWAN- RDN Strategy
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: July 13, 2017
• Start date: March 2011
• Est. completion date: June 2015

Study information

• Verified date: July 2017
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

Device:
• Thermocool®Rcatheter
The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter
• Thermocool®Rcatheter
The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter

Locations

Country	Name	City	State
China	2ndChongqingMU	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	office BP and Ambulatory blood pressure	one year
Secondary	ablation-related complications	ablation-related complications such as pseudoaneurysm,renal artery injury	one year