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ReferencesEfficiency and safety of renal denervation via cryoablation (Cryo-RDN) in Chinese patients with
Han Chen1, Meng Ji1,2, Yi Zhang3
1Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Insights
This study investigates cryoablation renal denervation (cryo-RDN) for uncontrolled hypertension in Chinese patients. Cryo-RDN shows promise as a new treatment to improve blood pressure control when added to medication.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Hypertension Management
Background:
- Many hypertensive patients have uncontrolled blood pressure despite lifestyle changes and medication adherence.
- Catheter-based renal denervation (RDN) is an emerging treatment for resistant hypertension.
- Previous RDN studies focused on non-Chinese populations using radiofrequency or ultrasound.
Purpose of the Study:
- To evaluate the safety and efficacy of cryoablation renal denervation (cryo-RDN) using the novel Cryofocus balloon catheter in Chinese patients with uncontrolled hypertension.
- To assess cryo-RDN as a supplementary treatment to standard medical therapy for improving hypertension control in China.
Main Methods:
- A prospective, multicenter, randomized, sham-controlled trial involving 200 Chinese patients with uncontrolled hypertension.
- Participants will be randomized 1:1 to receive cryo-RDN or a sham procedure (renal angiography alone) after drug standardization.
- The primary endpoint is the change in 24-hour ambulatory systolic blood pressure at 6 months; secondary endpoints include office BP and safety events.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- The study aims to confirm the safety and efficacy of cryo-RDN with Cryofocus catheters in Chinese patients with uncontrolled hypertension on multiple medications.
- The findings are expected to offer a new therapeutic option to enhance hypertension management in China, complementing existing drug therapies.
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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