Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

Abstract

INTRODUCTION:

Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy.

METHODS AND ANALYSIS:

This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population.

ETHICS AND DISSEMINATION:

All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China.

TRIAL REGISTRATION:

ClinicalTrials.gov ID: NCT02900729; pre-results.

• Authors: Zongjun Liu, Li Shen, Weijian Huang, Xianxian Zhao, Weiyi Fang, Changqian Wang, Zhaofang Yin, Jianan Wang, Guosheng Fu, Xuebo Liu, Jianjun Jiang, Zhihui Zhang, Jingbo Li, Yingmin Lu, Junbo Ge
• Journal: BMJ open (BMJ Open) Vol. 7 Issue 9 Pg. e015672 (Sep 01 2017) ISSN: 2044-6055 [Electronic] England
• PMID: 28864691 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Topics

• Adolescent
• Adult
• Aged
• Asian People
• Blood Pressure
• Catheter Ablation (methods)
• Denervation (methods)
• Essential Hypertension (therapy)
• Female
• Humans
• Hypertension (therapy)
• Kidney (innervation)
• Male
• Middle Aged
• Prospective Studies
• Renal Artery (surgery)
• Research Design
• Treatment Outcome
• Young Adult