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. 2020 Apr 21;41(16):1588-1599.
doi: 10.1093/eurheartj/ehaa121.

Proceedings from the 3rd European Clinical Consensus Conference for clinical trials in device-based hypertension therapies

Felix Mahfoud  1   2 , Michel Azizi  3   4   5 , Sebastian Ewen  1 , Atul Pathak  5   6 , Christian Ukena  1 , Peter J Blankestijn  7 , Michael Böhm  1 , Michel Burnier  8 , Gilles Chatellier  3   9 , Isabelle Durand Zaleski  10 , Guido Grassi  11 , Michael Joner  12   13 , David E Kandzari  14 , Ajay Kirtane  15 , Sverre E Kjeldsen  16 , Melvin D Lobo  17 , Thomas F Lüscher  18   19 , John William McEvoy  20 , Gianfranco Parati  21 , Patrick Rossignol  5   22   23 , Luis Ruilope  24 , Markus P Schlaich  25   26 , Atif Shahzad  20   27 , Faisal Sharif  20   27 , Andrew S P Sharp  28   29 , Horst Sievert  30   31   32   33 , Massimo Volpe  34 , Michael A Weber  35 , Roland E Schmieder  36 , Costas Tsioufis  37 , William Wijns  38
Affiliations

Proceedings from the 3rd European Clinical Consensus Conference for clinical trials in device-based hypertension therapies

Felix Mahfoud et al. Eur Heart J. .

Erratum in

No abstract available

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Figures

Figure 1
Figure 1
Explanatory vs. pragmatic trial on the example of RDN. Adapted from Thorpe et al.
Take home Figure
Take home Figure
Summary of research and development challenges in device-based hypertension treatment.
Figure 2
Figure 2
Suggested algorithm for identification of RDN candidates for clinical trials. CTA, computed tomography angiography; DUS, duplex ultrasound; MRA, magnetic resonance angiography.
Figure 3
Figure 3
Cost-effectiveness plane. Adapted from Bulsei et al.
None
See this image and copyright information in PMC

References

    1. Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL. A controlled trial of renal denervation for resistant hypertension. N Engl J Med 2014;370:1393–1401. - PubMed
    1. White WB, Galis ZS, Henegar J, Kandzari DE, Victor R, Sica D, Townsend RR, Turner JR, Virmani R, Mauri L. Renal denervation therapy for hypertension: pathways for moving development forward. J Am Soc Hypertens 2015;9:341–350. - PubMed
    1. Mahfoud F, Böhm M, Azizi M, Pathak A, Durand Zaleski I, Ewen S, Tsioufis K, Andersson B, Blankestijn PJ, Burnier M, Chatellier G, Gafoor S, Grassi G, Joner M, Kjeldsen SE, Lüscher TF, Lobo MD, Lotan C, Parati G, Redon J, Ruilope L, Sudano I, Ukena C, Leeuwen E. V, Volpe M, Windecker S, Witkowski A, Wijns W, Zeller T, Schmieder RE. Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design. Eur Heart J 2015;36:2219–2227. - PubMed
    1. Mahfoud F, Schmieder RE, Azizi M, Pathak A, Sievert H, Tsioufis C, Zeller T, Bertog S, Blankestijn PJ, Böhm M, Burnier M, Chatellier G, Durand Zaleski I, Ewen S, Grassi G, Joner M, Kjeldsen SE, Lobo MD, Lotan C, Lüscher Parati FT, Rossignol G, Ruilope P, Sharif L, Leeuwen F, van E, Volpe M, Windecker S, Witkowski A, Wijns W. Proceedings from the 2nd European Clinical Consensus Conference for device-based therapies for hypertension: state of the art and considerations for the future. Eur Heart J 2017;38:3272–3281. - PMC - PubMed
    1. Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Böhm M; SPYRAL HTN-OFF MED trial investigators. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet 2017;390:2160–2170. - PubMed

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