Full Length Versus Proximal Renal Arteries Ablation

NCT ID: NCT01848275

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-06-30

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.

Conditions

Hypertension, Resistant to Conventional Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Group 1 received ablation from distal to ostial of bilateral renal arteries

Group Type: ACTIVE_COMPARATOR

Thermocool®Rcatheter

Intervention Type: DEVICE

The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter

Group 2

group 2 received ablation at proximal of bilateral renal arteries

Group Type: EXPERIMENTAL

Thermocool®Rcatheter

Intervention Type: DEVICE

The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter

Interventions

Thermocool®Rcatheter

The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter

Intervention Type: DEVICE

Thermocool®Rcatheter

The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuehui Yin

Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

2ndChongqingMU

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

SWAN- RDN Strategy

Identifier Type: -

Identifier Source: org_study_id