Roland E Schmieder1, Christian Ott1, Stefan W Toennes2, Peter Bramlage3, Michael Gertner4, Omar Dawood5, Peter Baumgart6, Benjamin O'Brien7,8, Indranil Dasgupta9, Georg Nickenig10, John Ormiston11, Manish Saxena7, Andrew S P Sharp12, Horst Sievert13, Jindrich Spinar14,15, Zdenek Starek16, Joachim Weil17, Ulrich Wenzel18, Adam Witkowski19, Melvin D Lobo7. 1. Department of Nephrology and Hypertension, University Hospital of the Friedrich-Alexander University Erlangen-Nürnberg, Erlangen. 2. Institute of Legal Medicine, Forensic Toxicology Department, Goethe University, Frankfurt/Main. 3. Institute for Preventive Medicine, Mahlow, Germany. 4. Kona Medical, Department of Surgery, Stanford School of Medicine, Stanford, California. 5. Kona Medical, Bellevue, Washington, USA. 6. Medizinische Klinik I, Clemenshospital GmbH, Münster, Germany. 7. NIHR Barts Cardiovascular Biomedical Research Unit, William Harvey Research Institute. 8. St Bartholomew's Hospital, London. 9. Renal Unit, Heart of England NHS Foundation Trust, Birmingham, UK. 10. Kardiologie, Angiologie und Pneumologie, Universitätsklinikum Bonn, Bonn, Germany. 11. Mercy Angiography, Auckland, New Zealand. 12. Royal Exeter and Devon Hospital, Exeter, UK. 13. CardioVascular Center, Sankt Katharinen Hospital, Frankfurt, Germany. 14. Cardiology Department, University Hospital Brno. 15. Medical Faculty, Masaryk University Brno. 16. I. International Clinical Research Center, St. Anne's University Hospital, 1st Department of Internal Medicine/Cardioangiology, Brno, Czech Republic. 17. Medizinische Klinik II, Kardiologie und Angiologie, Sana Kliniken Lübeck, Lübeck. 18. Universitätsklinikum Hamburg-Eppendorf, III. Medizinische Klinik und Poliklinik Hamburg, Germany. 19. Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw, Poland.
Abstract
OBJECTIVES: The aim of this double-blind, randomized, sham-controlled study was to verify the blood pressure (BP)-lowering efficacy of externally delivered focused ultrasound for renal denervation (RDN). BACKGROUND: Nonrandomized, first proof-of-concept study and experimental evidence suggested that noninvasive techniques of RDN emerged as an alternative approach of RDN to invasive technologies. METHODS: WAVE IV, an international, randomized (1 : 1) sham-controlled, double-blind prospective clinical study, was prematurely stopped. Patients were enrolled if office BP was at least 160mmHg and 24-h ambulatory BP was at least 135 mmHg, while taking three or more antihypertensive medications. The treatment consisted of bilateral RDN using therapeutic levels of ultrasound energy and the sham consisted of bilateral application of diagnostic levels of ultrasound energy. RESULTS: In the 81 treated patients neither changes in office BP at 12 and 24 weeks, nor changes in 24-h ambulatory BP at 24-week follow-up visit differed between the two groups significantly. Of note, no safety signal was observed. Adherence analysis disclosed full adherence in 77% at baseline and 82% at 6 months' follow-up visit. Post hoc analysis revealed that stricter criteria for stabilization of BP at baseline were associated with a numerically greater change in 24-h ambulatory BP in the RDN group than in the sham group. CONCLUSION: Our data did not prove that antihypertensive efficacy of the externally delivered focused ultrasound for RDN was greater than the sham effect. Stabilization of BP at baseline was identified as an important determinant of BP changes.
RCT Entities:
OBJECTIVES: The aim of this double-blind, randomized, sham-controlled study was to verify the blood pressure (BP)-lowering efficacy of externally delivered focused ultrasound for renal denervation (RDN). BACKGROUND: Nonrandomized, first proof-of-concept study and experimental evidence suggested that noninvasive techniques of RDN emerged as an alternative approach of RDN to invasive technologies. METHODS: WAVE IV, an international, randomized (1 : 1) sham-controlled, double-blind prospective clinical study, was prematurely stopped. Patients were enrolled if office BP was at least 160 mmHg and 24-h ambulatory BP was at least 135 mmHg, while taking three or more antihypertensive medications. The treatment consisted of bilateral RDN using therapeutic levels of ultrasound energy and the sham consisted of bilateral application of diagnostic levels of ultrasound energy. RESULTS: In the 81 treated patients neither changes in office BP at 12 and 24 weeks, nor changes in 24-h ambulatory BP at 24-week follow-up visit differed between the two groups significantly. Of note, no safety signal was observed. Adherence analysis disclosed full adherence in 77% at baseline and 82% at 6 months' follow-up visit. Post hoc analysis revealed that stricter criteria for stabilization of BP at baseline were associated with a numerically greater change in 24-h ambulatory BP in the RDN group than in the sham group. CONCLUSION: Our data did not prove that antihypertensive efficacy of the externally delivered focused ultrasound for RDN was greater than the sham effect. Stabilization of BP at baseline was identified as an important determinant of BP changes.
Authors: Anna Pisano; Luigi Francesco Iannone; Antonio Leo; Emilio Russo; Giuseppe Coppolino; Davide Bolignano Journal: Cochrane Database Syst Rev Date: 2021-11-22
Authors: Melvin D Lobo; Andrew S P Sharp; Vikas Kapil; Justin Davies; Mark A de Belder; Trevor Cleveland; Clare Bent; Neil Chapman; Indranil Dasgupta; Terry Levy; Anthony Mathur; Matthew Matson; Manish Saxena; Francesco P Cappuccio Journal: Heart Date: 2019-07-10 Impact factor: 5.994
Authors: Manish Saxena; Tariq Shour; Mussadiq Shah; Christopher B Wolff; Peter O O Julu; Vikas Kapil; David J Collier; Fu Liang Ng; Ajay Gupta; Armida Balawon; Jane Pheby; Anne Zak; Gurvinder Rull; Benjamin O'Brien; Roland E Schmieder; Melvin D Lobo Journal: J Am Heart Assoc Date: 2018-06-12 Impact factor: 5.501