| Title: |
Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation Prespecified Analysis at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial |
| Authors: |
Azizi, M; Mahfoud, F; Weber, MA; Sharp, ASP; Schmieder, RE; Lurz, P; Lobo, MD; Fisher, NDL; Daemen, J; Bloch, MJ; Basile, J; Sanghvi, K; Saxena, M; Gosse, P; Jenkins, JS; Levy, T; Persu, A; Kably, B; Claude, L; Reeve-Stoffer, H; McClure, C; Kirtane, AJ |
| Publisher Information: |
American Medical Association |
| Publication Year: |
2022 |
| Collection: |
Queen Mary University of London: Queen Mary Research Online (QMRO) |
| Description: |
Importance Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial. Objectives To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications. Design, Setting, and Participants This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. This was an international, multicenter study conducted in the US and Europe. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m2 or greater were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment. Interventions uRDN vs sham procedure in conjunction with added medications to target BP control. Main Outcomes and Measures Six-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP and medications, and safety. Results A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m2 had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
1244 - 1252 |
| Language: |
unknown |
| Relation: |
JAMA CARDIOLOGY; https://qmro.qmul.ac.uk/xmlui/handle/123456789/101279 |
| DOI: |
10.1001/jamacardio.2022.3904 |
| Availability: |
https://qmro.qmul.ac.uk/xmlui/handle/123456789/101279; https://doi.org/10.1001/jamacardio.2022.3904 |
| Rights: |
: This is an open access article distributed under the terms of the CC-BY-NC-ND License. ; © 2022 Azizi M et al.JAMA Cardiology. |
| Accession Number: |
edsbas.F4FEF41C |
| Database: |
BASE |