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Randomized Controlled Trial
. 2024 Nov 12;150(20):1588-1598.
doi: 10.1161/CIRCULATIONAHA.124.069215. Epub 2024 Sep 4.

Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial

Xiongjing Jiang #  1 , Felix Mahfoud #  2 , Wei Li  3 , Hui Dong  1 , Jing Yu  4 , Shuhua Yu  5 , Xiaoping Chen  6 , Peijian Wang  7 , Zhiqiang Li  8 , Lucas Lauder  2 , Zhifang Wang  9 , Zheng Ji  10 , Yifei Dong  11 , Bing Han  12 , Zhiming Zhu  13 , Yulin Chen  14 , Jianzhong Xu  15 , Xingsheng Zhao  16 , Weidong Fan  17 , Wen Xie  18 , Brad Hubbard  19 , Xi Hu, Kazuomi Kario  20 , Runlin Gao  1
Affiliations
Randomized Controlled Trial

Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial

Xiongjing Jiang et al. Circulation. .

Abstract

Background: Renal denervation (RDN) can lower blood pressure (BP) in patients with hypertension in both the presence and absence of medication. This is a sham-controlled trial investigating the safety and efficacy of RDN in China.

Methods: This prospective, multicenter, randomized, patient- and outcome-assessor-blinded, sham-controlled trial investigated radiofrequency RDN in patients with hypertension on standardized triple antihypertensive therapy. Eligible patients were randomized 1:1 to undergo RDN using a multi-electrode radiofrequency catheter (Iberis; Shanghai Angiocare Medical Technology, Shanghai, China) or a sham procedure. The primary efficacy outcome was the between-group difference in baseline-adjusted change in mean 24-hour ambulatory systolic BP from randomization to 6 months.

Results: Of 217 randomized patients (mean age, 45.3±10.2 years; 21% female), 107 were randomized to RDN and 110 were randomized to sham control. At 6 months, there was a greater reduction in 24-hour systolic BP in the RDN (-13.0±12.1 mm Hg) compared with the sham control group (-3.0±13.0 mm Hg; baseline-adjusted between-group difference, -9.4 mm Hg [95% CI, -12.8 to -5.9]; P<0.001). Compared with sham, 24-hour diastolic BP was lowered by -5.0 mm Hg ([95% CI, -7.5 to -2.4]; P<0.001) 6 months after RDN, and office systolic and diastolic BP was lowered by -6.4 mm Hg ([95% CI, -10.5 to -2.3]; P=0.003) and -5.1 mm Hg ([95% CI, -8.2 to -2.0]; P=0.001), respectively. One patient in the RDN group experienced an access site complication (hematoma), which resolved without sequelae. No other major device- or procedure-related safety events occurred through follow-up.

Conclusions: In this trial of Chinese patients with uncontrolled hypertension on a standardized triple pharmacotherapy, RDN was safe and reduced ambulatory and office BP at 6 months compared with sham.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02901704.

Keywords: antihypertensive agents; blood pressure; denervation; hypertension.

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Conflict of interest statement

X. Jiang is supported by Iberis-HTN trial fund from Shanghai Angiocare Medical Technology, CAMS Innovation Fund for Medical Sciences (grant Nos. 2021-I2M-C&T-B-026 and 2021-I2M-C&T-B-027). He has received speaker honoraria fees from Medtronic and Terumo. Felix Mahfoud is supported by Deutsche Gesellschaft für Kardiologie, Deutsche Forschungsgemeinschaft (SFB TRR219, Project ID 322900939), and Deutsche Herzstiftung. He has received scientific support from Ablative Solutions, Medtronic, and ReCor Medical, and speaker honoraria/consulting fees from Ablative Solutions, Amgen, Astra-Zeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, ReCor Medical, Servier, and Terumo. L. Lauder received speaker honoraria/consulting fees from AstraZeneca, Medtronic, Pfizer, and ReCor. Brad Hubbard is an employee of EastPoint Innovation Center. X. Hu is an employee of Shanghai Angiocare Medical Technology. R. Gao received institutional research grants from Shanghai Angiocare Medical Technology (Shanghai, China) and Biotyx Medical (Shenzhen, China). The remaining authors report no conflicts of interest related to this article.

Figures

Figure 1.
Figure 1.
Patient flow chart. ABPM indicates ambulatory blood pressure monitoring; BP, blood pressure; CT, computed tomography; and eGFR, estimated glomerular filtration rate.
Figure 2.
Figure 2.
Changes in 24-hour and office systolic and diastolic blood pressure from baseline to 6 months. Between-group differences were adjusted for baseline measurements and are presented as mean (95% CI).
Figure 3.
Figure 3.
Ambulatory blood pressures: 24-hour profiles. Depicted are 24-hour ambulatory systolic (A) and diastolic (B) blood pressures at baseline and 6 months of the renal denervation and sham control groups. Error bars show SEM.
See this image and copyright information in PMC

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