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.
[1]Shanghai Tradit Chinese Med Univ, Dept Cardiol, Putuo Hosp, Shanghai, Peoples R China;
[2]Fu Dan Univ, Dept Cardiol, Zhongshan Hosp, Shanghai, Peoples R China;
[3]Wenzhou Med Coll, Dept Cardiol, Hosp 1, Wenzhou, Peoples R China;
[4]Second Mil Med Univ, Dept Cardiol, Changhai Hosp, Shanghai, Peoples R China;
[5]Shanghai Jiao Tong Univ, Dept Cardiol, Shanghai Chest Hosp, Shanghai, Peoples R China;
[6]Shanghai Jiao Tong Univ, Dept Cardiol, Shanghai Peoples Hosp 9, Shanghai, Peoples R China;
[7]Zhejiang Univ, Dept Cardiol, Hosp 2, Hangzhou, Peoples R China;
[8]Zhejiang Univ, Dept Cardiol, Sir Run Run Shaw Hosp, Hangzhou, Zhejiang, Peoples R China;
[9]Tongji Univ, Dept Cardiol, Tongji Hosp, Shanghai, Peoples R China;
[10]Taizhou Hosp, Dept Cardiol, Taizhou, Peoples R China;
[11]Cent S Univ, Dept Cardiol, Xiangya Hosp 3, Changsha, Hunan, Peoples R China;
[12]Shanghai Jiao Tong Univ, Dept Cardiol, Shanghai Peoples Hosp 6, Shanghai, Peoples R China;
[13]Shanghai Jiao Tong Univ, Dept Cardiol, Xinhua Hosp, Sch Med,Chongming Branch, Shanghai, Peoples R China
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