Full Length Versus Proximal Renal Arteries Ablation

Not Applicable

Completed

• Conditions: Hypertension, Resistant to Conventional Therapy
• Interventions: Device: Thermocool®Rcatheter

• Registration Number: NCT01848275
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-07
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Thermocool®Rcatheter	Group 1 received ablation from distal to ostial of bilateral renal arteries
Group 2	Thermocool®Rcatheter	group 2 received ablation at proximal of bilateral renal arteries

Primary Outcome Measures

Name	Time	Method
Blood pressure	one year	office BP and Ambulatory blood pressure

Secondary Outcome Measures

Name	Time	Method
ablation-related complications	one year	ablation-related complications such as pseudoaneurysm，renal artery injury

Trial Locations

Locations (1)

2ndChongqingMU; 🇨🇳 Chongqing, Chongqing, China