Abstract
BackgroundClinical 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/designThis 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.DiscussionThis 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 registrationChiCTR, ChiCTR1800017707. Registered on 10 August 2018.
Highlights
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
The aim is to provide a new way to improve the control of hypertension in China as a complement to drug therapy
To explore the safety and feasibility of cryo-renal denervation (RDN) in Chinese patients with uncontrolled hypertension further, we have developed a rationale and methodology for a prospective multicenter randomized sham-controlled trial using a 7.5F cryoablation catheter from the Cryofocus system
Summary
This study was designed to assess the safety and efficacy of cryo-RDN using Cryofocus balloon catheters in patients taking polypharmacy with uncontrolled hypertension. Recent results from the First-in-man study showed that the mean ambultory blood pressure reduction was 11.8/8.0 mmHg at the 6-month follow-up of six patients with uncontrolled hypertension Based on these results, we focused on the safety and efficacy in the longer term for a larger population. Previous animal experiments have revealed that (1) cryoablation is more penetrating than radio waves, resulting in fewer (neurofilament light)-positive nerves remaining [21, 22], (2) cryoenergy is more protective and friendlier to peripheral tissues than radio waves in arrythmia ablation [23,24,25,26], (3) radiofrequency catheters ablate lesions circumferentially but the lesions vary in shape, area, and diameter depending on the adjacent tissue substructures Based on these potential advantages, we constructed a special cryoablation balloon with a spherical ablation pattern.
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