Phase II randomized sham-controlled study of renal denervation
for individuals with uncontrolled hypertension - WAVE IV

J 2018

Phase II randomized sham-controlled study of renal denervation for individuals with uncontrolled hypertension - WAVE IV

SCHMIEDER, R.E., C. OTT, S.W. TOENNES, P. BRAMLAGE, M. GERTNER et. al.

Basic information

Original name

Phase II randomized sham-controlled study of renal denervation for individuals with uncontrolled hypertension - WAVE IV

Authors

SCHMIEDER, R.E. (276 Germany, guarantor), C. OTT (276 Germany), S.W. TOENNES (276 Germany), P. BRAMLAGE (276 Germany), M. GERTNER (840 United States of America), O. DAWOOD (840 United States of America), P. BAUMGART (276 Germany), B. O'BRIEN (826 United Kingdom of Great Britain and Northern Ireland), I. DASGUPTA (826 United Kingdom of Great Britain and Northern Ireland), G. NICKENIG (276 Germany), J. ORMISTON (554 New Zealand), M. SAXENA (826 United Kingdom of Great Britain and Northern Ireland), A.S.P. SHARP (826 United Kingdom of Great Britain and Northern Ireland), H. SIEVERT (276 Germany), Jindřich ŠPINAR (203 Czech Republic, belonging to the institution), Zdeněk STÁREK (203 Czech Republic), J. WEIL (276 Germany), U. WENZEL (276 Germany), A. WITKOWSKI (616 Poland) and M.D. LOBO (826 United Kingdom of Great Britain and Northern Ireland)

Edition

Journal of Hypertension, PHILADELPHIA, William and Wilkins, 2018, 0263-6352

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 4.209

RIV identification code

RIV/00216224:14110/18:00103132

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1097/HJH.0000000000001584

UT WoS

000429317500029

Keywords in English

renal denervation; treatment-resistant hypertension; ultrasound; WAVE IV

Abstract

V originále

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.

Citovat

SCHMIEDER, R.E., C. OTT, S.W. TOENNES, P. BRAMLAGE, M. GERTNER, O. DAWOOD, P. BAUMGART, B. O'BRIEN, I. DASGUPTA, G. NICKENIG, J. ORMISTON, M. SAXENA, A.S.P. SHARP, H. SIEVERT, Jindřich ŠPINAR, Zdeněk STÁREK, J. WEIL, U. WENZEL, A. WITKOWSKI and M.D. LOBO. Phase II randomized sham-controlled study of renal denervation for individuals with uncontrolled hypertension - WAVE IV. Journal of Hypertension. PHILADELPHIA: William and Wilkins, 2018, vol. 36, No 3, p. 680-689. ISSN 0263-6352. Available from: https://dx.doi.org/10.1097/HJH.0000000000001584.

@article{1422336,
   author = {Schmieder, R.E. and Ott, C. and Toennes, S.W. and Bramlage, P. and Gertner, M. and Dawood, O. and Baumgart, P. and O'Brien, B. and Dasgupta, I. and Nickenig, G. and Ormiston, J. and Saxena, M. and Sharp, A.S.P. and Sievert, H. and Špinar, Jindřich and Stárek, Zdeněk and Weil, J. and Wenzel, U. and Witkowski, A. and Lobo, M.D.},
   article_location = {PHILADELPHIA},
   article_number = {3},
   doi = {http://dx.doi.org/10.1097/HJH.0000000000001584},
   keywords = {renal denervation; treatment-resistant hypertension; ultrasound; WAVE IV},
   language = {eng},
   issn = {0263-6352},
   journal = {Journal of Hypertension},
   title = {Phase II randomized sham-controlled study of renal denervation for individuals with uncontrolled hypertension - WAVE IV},
   url = {https://journals.lww.com/jhypertension/Fulltext/2018/03000/Phase_II_randomized_sham_controlled_study_of_renal.30.aspx},
   volume = {36},
   year = {2018}
}

TY  - JOUR
ID  - 1422336
AU  - Schmieder, R.E. - Ott, C. - Toennes, S.W. - Bramlage, P. - Gertner, M. - Dawood, O. - Baumgart, P. - O'Brien, B. - Dasgupta, I. - Nickenig, G. - Ormiston, J. - Saxena, M. - Sharp, A.S.P. - Sievert, H. - Špinar, Jindřich - Stárek, Zdeněk - Weil, J. - Wenzel, U. - Witkowski, A. - Lobo, M.D.
PY  - 2018
TI  - Phase II randomized sham-controlled study of renal denervation for individuals with uncontrolled hypertension - WAVE IV
JF  - Journal of Hypertension
VL  - 36
IS  - 3
SP  - 680-689
EP  - 680-689
PB  - William and Wilkins
SN  - 02636352
KW  - renal denervation
KW  - treatment-resistant hypertension
KW  - ultrasound
KW  - WAVE IV
UR  - https://journals.lww.com/jhypertension/Fulltext/2018/03000/Phase_II_randomized_sham_controlled_study_of_renal.30.aspx
N2  - 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.
ER  -

SCHMIEDER, R.E., C. OTT, S.W. TOENNES, P. BRAMLAGE, M. GERTNER, O. DAWOOD, P. BAUMGART, B. O'BRIEN, I. DASGUPTA, G. NICKENIG, J. ORMISTON, M. SAXENA, A.S.P. SHARP, H. SIEVERT, Jindřich ŠPINAR, Zdeněk STÁREK, J. WEIL, U. WENZEL, A. WITKOWSKI and M.D. LOBO. Phase II randomized sham-controlled study of renal denervation for individuals with uncontrolled hypertension - WAVE IV. \textit{Journal of Hypertension}. PHILADELPHIA: William and Wilkins, 2018, vol.~36, No~3, p.~680-689. ISSN~0263-6352. Available from: https://dx.doi.org/10.1097/HJH.0000000000001584.

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