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BMJ Open. 2017 Sep 1;7(9):e015672. doi: 10.1136/bmjopen-2016-015672.

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.

Author information

1
Department of Cardiology, Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University, Shanghai, China.
2
Department of Cardiology, Zhongshan Hospital affiliated to Fu Dan University, Shanghai, China.
3
Department of Cardiology, The First Hospital affiliated to Wenzhou Medical College, Wenzhou, China.
4
Department of Cardiology, Changhai Hospital affiliated to Second Military Medical University, Shanghai, China.
5
Department of Cardiology, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University, Shanghai, China.
6
Department of Cardiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, Shanghai, China.
7
Department of Cardiology, The Second Hospital affiliated to Zhejiang University, Hangzhou, China.
8
Department of Cardiology, Sir Run Run Shaw Hospital affiliated to Zhejiang University, Hangzhou, China.
9
Department of Cardiology, Tongji Hospital affiliated to Tongji University, Shanghai, China.
10
Department of Cardiology, Taizhou Hospital, Taizhou, China.
11
Department of Cardiology, The Third Xiangya Hospital of Central South University, China.
12
Department of Cardiology, Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University, Shanghai, China.
13
Department of Cardiology, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch, Shanghai, China.

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.

KEYWORDS:

Chinese patients; ambulatory blood pressure; radiofrequency ablation; renal denervation; resistant hypertension

PMID:
28864691
PMCID:
PMC5588951
DOI:
10.1136/bmjopen-2016-015672
[Indexed for MEDLINE]
Free PMC Article

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