Key result
This study protocol outlines a randomized sham-controlled trial to evaluate whether cryoablation renal denervation reduces 24-hour ambulatory systolic blood pressure at 6 months in Chinese patients with uncontrolled hypertension.
Why the study?
Prior studies confirming the safety and efficacy of catheter-based RDN were conducted in non-Chinese participants using radiofrequency or ultrasound, leaving cryoablation RDN unstudied in Chinese patients with uncontrolled hypertension.
Does cryoablation renal denervation reduce 24-h ambulatory systolic blood pressure in Chinese patients with uncontrolled hypertension?
RCT (n=200)
Single-blind
1:1 stratified block randomization
Yes
Does cryoablation renal denervation reduce 24-h ambulatory systolic blood pressure in Chinese patients with uncontrolled hypertension?
This study protocol describes a randomized sham-controlled trial to evaluate the safety and efficacy of cryoablation renal denervation in Chinese patients with uncontrolled hypertension.
BACKGROUND: Clinical data show that due to the limited effects of lifestyle regulation and unsatisfactory drug adherence, only half of the hypertensive population have their blood pressure (BP) under control. In recent years, catheter-based renal denervation (RDN) has been used as a novel approach for treating uncontrolled hypertension. The safety and efficacy of catheter-based RDN have been confirmed by a number of studies and trials in which the participants were all non-Chinese and RDN was conducted via radiofrequency or ultrasound. METHODS/DESIGN: This study is a prospective multicenter randomized sham-controlled trial that aims to investigate the safety and efficacy of cryoablation RDN (cryo-RDN) using a novel dedicated cryoablation balloon catheter (Cryofocus, China). A total of 200 Chinese patients who have uncontrolled hypertension despite standard medical treatment will be enrolled. With drug standardization, eligible participants will be randomized in a 1:1 ratio to undergo cryo-RDN treatment or renal angiography alone as a sham treatment. The primary endpoint is defined as the change in 24-h ambulatory systolic blood pressure from baseline to 6 months. Office BP and other 24-h ambulatory BP are included as secondary endpoints. Safety endpoints primarily include any adverse effects. DISCUSSION: This study was designed to verify the safety and efficacy of cryo-RDN with Cryofocus balloon catheters in uncontrolled hypertensive patients on polypharmacy. The aim is to provide a new way to improve the control of hypertension in China as a complement to drug therapy. TRIAL REGISTRATION: ChiCTR, ChiCTR1800017707. Registered on 10 August 2018.
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Chen et al. (2019) conducted an RCT in Uncontrolled hypertension (n=200). Cryoablation renal denervation (cryo-RDN) vs. Renal angiography alone (sham treatment) was evaluated on Difference in the change in 24-h ambulatory systolic blood pressure from baseline to 6 months. This study protocol outlines a randomized sham-controlled trial to evaluate whether cryoablation renal denervation reduces 24-hour ambulatory systolic blood pressure at 6 months in Chinese patients with uncontrolled hypertension.
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