# RF-renale denervatie bij ongecontroleerde hypertensie in China: gerandomiseerde trial

*geplaatst 2024-11-12 · Hypertensie · Circulation · doi 10.1161/CIRCULATIONAHA.124.069215 · https://hartvaat.nl/2024/11/12/rf-renale-denervatie-bij-ongecontroleerde-hypertensie-in-china-gerandomiseerde-t/*

Gerandomiseerde trial bevestigde de effectiviteit van katheter-gebaseerde RF renale denervatie bij Chinese patiënten met ongecontroleerde hypertensie. Het bloeddrukverlagende effect is consistent over etnische groepen.

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

This sham-controlled trial confirmed the efficacy of catheter-based radiofrequency renal denervation in Chinese patients with uncontrolled hypertension, extending the evidence for device-based therapy to the Asian hypertensive population.

## Abstract (original, from the publication)

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.

Auteurs: Xiongjing Jiang, Felix Mahfoud, Wei Li, Hui Dong, Jing Yu, Shuhua Yu, Xiaoping Chen, Peijian Wang, Zhiqiang Li, Lucas Lauder, Zhifang Wang, Zheng Ji, Yifei Dong, Bing Han, Zhiming Zhu, Yulin Chen, Jianzhong Xu, Xingsheng Zhao, Weidong Fan, Wen Xie, Brad Hubbard, Xi Hu, Kazuomi Kario, Runlin Gao

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Bron: Circulation, https://doi.org/10.1161/CIRCULATIONAHA.124.069215. Bijgewerkt 2026-07-03T18:39:13Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.