Key result
This study protocol describes a randomized controlled trial enrolling 254 Chinese patients to evaluate renal denervation plus medication versus medication alone for resistant hypertension.
Why the study?
Does renal denervation using a 5F saline-irrigated radiofrequency ablation reduce 24 hours average ambulatory systolic blood pressure in Chinese patients with resistant hypertension?
RCT (n=254)
Open-label
1:1
Yes
Does renal denervation using a 5F saline-irrigated radiofrequency ablation reduce 24 hours average ambulatory systolic blood pressure in Chinese patients with resistant hypertension?
This is a study protocol for a multicenter randomized controlled trial evaluating the efficacy and safety of renal denervation using a microirrigated catheter in Chinese patients with resistant hypertension.
Protocol outlines RCT of renal denervation in Chinese resistant hypertension; leaves open efficacy until results reported.
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.
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Liu et al. (2017) conducted an RCT in Resistant hypertension (n=254). Renal denervation using a 5F saline-irrigated radiofrequency ablation (RFA) plus antihypertensive medication vs. Antihypertensive medication alone was evaluated on Change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months. This study protocol describes a randomized controlled trial enrolling 254 Chinese patients to evaluate renal denervation plus medication versus medication alone for resistant hypertension.
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