{"id":"297470bd0787","type":"article","url":"https://hartvaat.nl/2024/11/12/rf-renale-denervatie-bij-ongecontroleerde-hypertensie-in-china-gerandomiseerde-t/","title":"RF-renale denervatie bij ongecontroleerde hypertensie in China: gerandomiseerde trial","title_en":"Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["bloeddrukbehandeling","chronische-nierziekte","fidelio-dkd","figaro-dkd","flow-trial","radiance-htn","renale-denervatie"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069215","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069215","authors":["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"],"significance":6,"published":"2024-11-12","source_date":"2024-11-12","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/","https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/"],"congress":"","summary_en":"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.","created":"2026-07-03T10:31:18Z","updated":"2026-07-03T18:39:13Z","licence":"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.","body_markdown":"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.","abstract_original":"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."}