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Cited by 740Blood Pressure and Hypertension StudiesRenal and Vascular PathologiesCardiovascular Health and Disease Prevention

The DOI matches its Crossref record; 29 of the 30 references it cites were found in a registry or an index.

Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial

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Azizi, Michel, Schmieder, Roland E, Mahfoud, Felix, Weber, Michael A, Daemen, Joost, Davies, Justin, Basile, Jan, Kirtane, Ajay J, Wang, Yale, Lobo, Melvin D, Saxena, Manish, Feyz, Lida, Rader, Florian, Lurz, Philipp, Sayer, Jeremy, Sapoval, Marc, Levy, Terry, Sanghvi, Kintur, Abraham, Josephine, Sharp, Andrew S P, Fisher, Naomi D L, Bloch, Michael J, Reeve-Stoffer, Helen, Coleman, Leslie, Mullin, Christopher, Mauri, Laura, Wang, Yale, Jay, Desmond, Skeik, Nedaa, Schwartz, Robert, Rader, Florian, Dohad, Suhail, Victor, Ronald, Sanghvi, Kintur, Costello, Josh, Walsh, Courtney, Abraham, Josephine, Owan, Theophilus, Abraham, Anu, Fisher, Naomi D.L., Mauri, Laura, Sobieszczky, Piotr, Williams, Jonathan, Bloch, Michael J., Roongsritong, Chanwit, Todoran, Thomas, Basile, Jan, Powers, Eric, Hodskins, Emily, Fong, Pete, Laffer, Cheryl, Gainer, James, Robbins, Mark, Reilly, John P., Cash, Michael, Goldman, Jessie, Aggarwal, Sandeep, Ledley, Gary, Hsi, David, Martin, Scott, Portnay, Edward, Calhoun, David, McElderry, Thomas, Maddox, William, Oparil, Suzanne, Huang, Pei-Hsiu, Jose, Powell, Khuddus, Matheen, Zentko, Suzanne, O'Meara, James, Barb, Ilie, Garasic, Joseph, Drachman, Doug, Zusman, Randy, Rosenfield, Kenneth, Devireddy, Chandan, Lea, Janice, Wells, Bryan, Stouffer, Rick, Hinderliter, Alan, Pauley, Eric, Potluri, Srinivasa, Biedermann, Scott, Bangalore, Sripal, Williams, Stephen, Zidar, David, Shishehbor, Mehdi, Effron, Barry, Costa, Marco, Kirtane, Ajay J., Radhakrishnan, Jai, Lobo, Melvin D., Saxena, Manish, Mathur, Anthony, Jain, Ajay, Sayer, Jeremy, Iyer, Sudha Ganesh, Robinson, Nicholas, Edroos, Sadat Ali, Levy, Terry, Patel, Amit, Beckett, David, Bent, Clare, Davies, Justin, Chapman, Neil, Shun-Shin, Matthew, Howard, James, Sharp, Andrew S.P., Joseph, Anil, D'Souza, Richard, Gerber, Robert, Faris, Mohamad, Marshall, Andrew J., Elorz, Cristina, Lurz, Philipp, Höllriegel, Robert, Fengler, Karl, Rommel, Karl-Philipp, Mahfoud, Felix, Böhm, Michael, Ewen, Sebastian, Lucic, Jelena, Schmieder, Roland E., Ott, Christian, Schmid, Axel, Uder, Michael, Rump, L. Christian, Stegbauer, Johannes, Kröpil, Patric, Azizi, Michel, Sapoval, Marc, Cornu, Erika, Fouassier, David, Gosse, Philippe, Cremer, Antoine, Trillaud, Hervé, Papadopoulos, Panteleimon, Pathak, Atul, Honton, Benjamin, Lantelme, Pierre, Berge, Constance, Courand, Pierre-Yves, Daemen, Joost, Feyz, Lida, Blankestijn, Peter J., Voskuil, Michiel, Rittersma, Zwaantina, Kroon, A.A., van Zwam, W.H., Persu, Alexandre, Renkin, Jean·2018·The Lancet
DOI 10.1016/s0140-6736(18)31082-1
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Abstract

BACKGROUND: Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications. METHODS: RADIANCE-HTN SOLO was a multicentre, international, single-blind, randomised, sham-controlled trial done at 21 centres in the USA and 18 in Europe. Patients with combined systolic-diastolic hypertension aged 18-75 years were eligible if they had ambulatory blood pressure greater than or equal to 135/85 mm Hg and less than 170/105 mm Hg after a 4-week discontinuation of up to two antihypertensive medications and had suitable renal artery anatomy. Patients were randomised (1:1) to undergo renal denervation with the Paradise system (ReCor Medical, Palo Alto, CA, USA) or a sham procedure consisting of renal angiography only. The randomisation sequence was computer generated and stratified by centres with randomised blocks of four or six and permutation of treatments within each block. Patients and outcome assessors were blinded to randomisation. The primary effectiveness endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified blood pressure criteria were exceeded. Major adverse events included all-cause mortality, renal failure, an embolic event with end-organ damage, renal artery or other major vascular complications requiring intervention, or admission to hospital for hypertensive crisis within 30 days and new renal artery stenosis within 6 months. This study is registered with ClinicalTrials.gov, number NCT02649426. FINDINGS: Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo renal denervation (n=74) or a sham procedure (n=72). The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (-8·5 mm Hg, SD 9·3) than with the sham procedure (-2·2 mm Hg, SD 10·0; baseline-adjusted difference between groups: -6·3 mm Hg, 95% CI -9·4 to -3·1, p=0·0001). No major adverse events were reported in either group. INTERPRETATION: Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic-diastolic hypertension in the absence of medications. FUNDING: ReCor Medical.

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Authors
Azizi, M., Schmieder, R. E., Mahfoud, F., Weber, M. A., Daemen, J., Davies, J., Basile, J., Kirtane, A. J., Wang, Y., Lobo, M. D., Saxena, M., Feyz, L., Rader, F., Lurz, P., Sayer, J., Sapoval, M., Levy, T., Sanghvi, K., Abraham, J., Sharp, A. S. P., Fisher, N. D. L., Bloch, M. J., Reeve-Stoffer, H., Coleman, L., Mullin, C., Mauri, L., Wang, Y., Jay, D., Skeik, N., Schwartz, R., Rader, F., Dohad, S., Victor, R., Sanghvi, K., Costello, J., Walsh, C., Abraham, J., Owan, T., Abraham, A., Fisher, N. D. L., Mauri, L., Sobieszczky, P., Williams, J., Bloch, M. J., Roongsritong, C., Todoran, T., Basile, J., Powers, E., Hodskins, E., Fong, P., Laffer, C., Gainer, J., Robbins, M., Reilly, J. P., Cash, M., Goldman, J., Aggarwal, S., Ledley, G., Hsi, D., Martin, S., Portnay, E., Calhoun, D., McElderry, T., Maddox, W., Oparil, S., Huang, P.-H., Jose, P., Khuddus, M., Zentko, S., O'Meara, J., Barb, I., Garasic, J., Drachman, D., Zusman, R., Rosenfield, K., Devireddy, C., Lea, J., Wells, B., Stouffer, R., Hinderliter, A., Pauley, E., Potluri, S., Biedermann, S., Bangalore, S., Williams, S., Zidar, D., Shishehbor, M., Effron, B., Costa, M., Kirtane, A. J., Radhakrishnan, J., Lobo, M. D., Saxena, M., Mathur, A., Jain, A., Sayer, J., Iyer, S. G., Robinson, N., Edroos, S. A., Levy, T., Patel, A., Beckett, D., Bent, C., Davies, J., Chapman, N., Shun-Shin, M., Howard, J., Sharp, A. S. P., Joseph, A., D'Souza, R., Gerber, R., Faris, M., Marshall, A. J., Elorz, C., Lurz, P., Höllriegel, R., Fengler, K., Rommel, K.-P., Mahfoud, F., Böhm, M., Ewen, S., Lucic, J., Schmieder, R. E., Ott, C., Schmid, A., Uder, M., Rump, L. C., Stegbauer, J., Kröpil, P., Azizi, M., Sapoval, M., Cornu, E., Fouassier, D., Gosse, P., Cremer, A., Trillaud, H., Papadopoulos, P., Pathak, A., Honton, B., Lantelme, P., Berge, C., Courand, P.-Y., Daemen, J., Feyz, L., Blankestijn, P. J., Voskuil, M., Rittersma, Z., Kroon, A. A., van Zwam, W. H., Persu, A., & Renkin, J.
Affiliations
  • State University of New York (US)
  • ReCor Medical (United States) (US)
  • NewYork–Presbyterian Hospital (US)
  • University of Utah (US)
  • University of Nevada, Reno (US)
  • Lyon 1 Université (FR)
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2018-06
Volume
391
Issue
10137
Pages
2335-2345
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(18)31082-1
OpenAlex
W2803910972
Cited by
740
References
30
Citations by year
2026: 56 · 2025: 67 · 2024: 88 · 2023: 105 · 2022: 94 · 2021: 101 · 2020: 91 · 2019: 96 · 2018: 41
FWCI
62.23
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet (publishedVersion, other-oa)
  • PubMed (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
  • HAL (submittedVersion)
  • HAL (submittedVersion, cc-by-nc-nd)
  • Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
  • Royal Devon and Exeter Research Repository (Royal Devon and Exeter) (submittedVersion)
Funders
  • ReCor Medical
  • National Institute for Health and Care Research (CL-2018-21-001)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Nephrology › Renal and Vascular Pathologies
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
Keywords
hypertension, ambulatory blood pressure, radiofrequency renal denervation, antihypertensive medication withdrawal, renal artery stenosis, major adverse events, hypertensive crisis, renal failure, embolic events
MeSH terms
Adolescent, Adult, Aged, Denervation, Female, Humans, Hypertension, Kidney, Male, Middle Aged, Renal Artery, Ultrasonography, Single-Blind Method, Treatment Outcome, Blood Pressure Monitoring, Ambulatory, Young Adult, Endovascular Procedures

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