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Open Access 01-12-2019 | Neurotomy | Study protocol
Efficiency and safety of renal denervation via cryoablation (Cryo-RDN) in Chinese patients with uncontrolled hypertension: study protocol for a randomized controlled trial
Published in: Trials | Issue 1/2019
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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.