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OpenTrials
Completed

NCT Number: NCT01848275

Full Length Versus Proximal Renal Arteries Ablation

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Thermocool®Rcatheter

Device

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

Primary outcomes

  1. Blood pressure

    Time frame: one year

    office BP and Ambulatory blood pressure

Secondary outcomes

  1. ablation-related complications

    Time frame: one year

    ablation-related complications such as pseudoaneurysm,renal artery injury

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
May 7, 2013
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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