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

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 +143 more·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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  • In the RADIANCE trials, renal denervation lowered blood pressure compared with sham, producing an approximately 6-mmHg decrease in daytime ambulatory systolic blood pressure.

    “In all three trials, RDN reduced blood pressure relative to a sham procedure, resulting in an approximately 6-mmHg decrease in daytime ambulatory SBP.”

    From Renal nerves in physiology, pathophysiology and interoception (2025) · cites this paper as [12]

    The Results report a 6.3-mmHg greater reduction in daytime ambulatory systolic blood pressure with renal denervation than with sham at 2 months, supporting the approximate 6-mmHg comparison. This paper reports the RADIANCE-HTN SOLO trial, however, and does not establish the claim about all three trials. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • In overweight patients with hypertension who were not taking antihypertensive medications, endovascular ultrasound renal denervation caused significantly greater reductions in 24-hour ambulatory systolic blood pressure at 2 months than did a sham procedure.

    “In overweight patients with hypertension who were not taking antihypertensive medications, endovascular ultrasound RDN caused significantly greater reductions in 24-hour ambulatory systolic BP at 2 months than did a sham procedure166.”

    From Obesity, kidney dysfunction and hypertension: mechanistic links (2019) · cites this paper as [166]

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  1. James KE, Bloch DA, Lee KK, Kraemer HC, Fuller RK. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation-a VA cooperative study. Stat Med 1996; 15: 1421-34.

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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 · 2017: 1
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 › Pulmonary and Respiratory Medicine › 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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