| Title: |
Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. |
| Authors: |
Kandzari, DE; Böhm, M; Mahfoud, F; Townsend, RR; Weber, MA; Pocock, S; Tsioufis, K; Tousoulis, D; Choi, JW; East, C; Brar, S; Cohen, SA; Fahy, M; Pilcher, G; Kario, K; SPYRAL HTN-ON MED Trial Investigators; COLLABORATORS; Aoki, J; Batson, B; Cohen, DL; Dangas, G; David, S; Davies, J; Devireddy, CM; Kandzari, D; Lee, DP; Lurz, PC; Papademetriou, V; Patel, M; Patel, K; Schmieder, RE; Sharp, ASP; Singh, J; Walton, A; Weber, T; Weil, J; Zeller, T; Ziada, K; Tanabe, K; Wilkins, R; Wilensky, R; Contreras, J; Steigerwalt, S; Chapman, N; Lea, JP; Reedus, D; Hoshide, S; Ma, A; Fengler, K; Li, P; Svetkey, L; Rao, A; Schmid, A; Watkinson, AF; Brown, A; Hopper, I; Suppan, M; Agdirlioglu, T; Noory, E; Chasen, C |
| Publisher Information: |
Elsevier |
| Publication Year: |
2018 |
| Collection: |
London School of Hygiene & Tropical Medicine: LSHTM Research Online |
| Description: |
Previous catheter-based renal denervation studies have reported variable efficacy results. We aimed to evaluate safety and blood pressure response after renal denervation or sham control in patients with uncontrolled hypertension on antihypertensive medications with drug adherence testing. : In this international, randomised, single-blind, sham-control, proof-of-concept trial, patients with uncontrolled hypertension (aged 20-80 years) were enrolled at 25 centres in the USA, Germany, Japan, UK, Australia, Austria, and Greece. Eligible patients had an office systolic blood pressure of between 150 mm Hg and 180 mm Hg and a diastolic blood pressure of 90 mm Hg or higher; a 24 h ambulatory systolic blood pressure of between 140 mm Hg and 170 mm Hg at second screening; and were on one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned to undergo renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were masked to randomisation assignments. The primary efficacy endpoint was blood pressure change from baseline (measured at screening visit two), based on ambulatory blood pressure measurements assessed at 6 months, as compared between treatment groups. Drug surveillance was used to assess medication adherence. The primary analysis was done in the intention-to-treat population. Safety events were assessed through 6 months as per major adverse events. This trial is registered with ClinicalTrials.gov, number NCT02439775, and follow-up is ongoing. : Between July 22, 2015, and June 14, 2017, 467 patients were screened and enrolled. This analysis presents results for the first 80 patients randomly assigned to renal denervation (n=38) and sham control (n=42). Office and 24 h ambulatory blood pressure decreased significantly from baseline to 6 months in the renal denervation group (mean baseline-adjusted treatment differences in 24 h systolic blood pressure -7·0 mm Hg, 95% CI -12·0 to -2·1; p=0·0059, 24 h ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
0140-6736 |
| Relation: |
https://researchonline.lshtm.ac.uk/id/eprint/4647923/1/Renal%20denervation%20in%20the%20presence%20of%20antihypertensive%20medications_GREEN%20AAM.pdf; Kandzari, DE; Böhm, M; Mahfoud, F; Townsend, RR; Weber, MA; Pocock, S ; Tsioufis, K; Tousoulis, D; Choi, JW; East, C; +57 more.Brar, S; Cohen, SA; Fahy, M; Pilcher, G; Kario, K; SPYRAL HTN-ON MED Trial Investigators; , COLLABORATORS; Aoki, J; Batson, B; Böhm, M; Choi, JW; Cohen, DL; Dangas, G; David, S; Davies, J; Devireddy, CM; Kandzari, D; Kario, K; Lee, DP; Lurz, PC; Papademetriou, V; Patel, M; Patel, K; Schmieder, RE; Sharp, ASP; Singh, J; Tsioufis, K; Walton, A; Weber, T; Weil, J; Zeller, T; Ziada, K; Tanabe, K; Wilkins, R; Mahfoud, F; East, C; Wilensky, R; Contreras, J; Steigerwalt, S; Chapman, N; Lea, JP; Reedus, D; Hoshide, S; Ma, A; Fengler, K; Li, P; Svetkey, L; Rao, A; Schmid, A; Watkinson, AF; Brown, A; Tousoulis, D; Hopper, I; Suppan, M; Agdirlioglu, T; Noory, E; and Chasen, C (2018) Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. ISSN 0140-6736 DOI:10.1016/S0140-6736(18)30951-6 |
| Availability: |
https://researchonline.lshtm.ac.uk/id/eprint/4647923/; https://researchonline.lshtm.ac.uk/id/eprint/4647923/1/Renal%20denervation%20in%20the%20presence%20of%20antihypertensive%20medications_GREEN%20AAM.pdf |
| Rights: |
cc_by_nc_nd |
| Accession Number: |
edsbas.3754F96A |
| Database: |
BASE |