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Cited by 2,242Blood Pressure and Hypertension StudiesRenal and Vascular PathologiesHormonal Regulation and Hypertension

Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial

‡·2010·The Lancet
DOI 10.1016/s0140-6736(10)62039-9
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Abstract

Background Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension.Methods In this multicentre, prospective, randomised trial, patients who had a baseline systolic blood pressure of 160 mm Hg or more (≥150 mm Hg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs, were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centres. Randomisation was done with sealed envelopes. Data analysers were not masked to treatment assignment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Primary analysis included all patients remaining in follow-up at 6 months. This trial is registered with ClinicalTrials.gov, number NCT00888433.Findings 106 (56%) of 190 patients screened for eligibility were randomly allocated to renal denervation (n=52) or control (n=54) groups between June 9, 2009, and Jan 15, 2010. 49 (94%) of 52 patients who underwent renal denervation and 51 (94%) of 54 controls were assessed for the primary endpoint at 6 months. Office-based blood pressure measurements in the renal denervation group reduced by 32/12 mm Hg (SD 23/11, baseline of 178/96 mm Hg, p<0·0001), whereas they did not differ from baseline in the control group (change of 1/0 mm Hg [21/10], baseline of 178/97 mm Hg, p=0·77 systolic and p=0·83 diastolic). Between-group differences in blood pressure at 6 months were 33/11 mm Hg (p<0·0001). At 6 months, 41 (84%) of 49 patients who underwent renal denervation had a reduction in systolic blood pressure of 10 mm Hg or more, compared with 18 (35%) of 51 controls (p<0·0001). We noted no serious procedure-related or device-related complications and occurrence of adverse events did not differ between groups; one patient who had renal denervation had possible progression of an underlying atherosclerotic lesion, but required no treatment.Interpretation Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients.Funding Ardian.

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  • Efferent sympathetic renal denervation can be achieved with luminal delivery of radiofrequency and ultrasonic energy.

    “Efferent sympathetic renal denervation can be achieved with luminal delivery of radiofrequency and ultrasonic energy.”

    From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [118]

  • Two device-based therapies targeting the sympathetic nervous system were developed: the surgically implanted barostimulator device and catheter-based renal denervation.

    “This was the development of two device-based therapies targeting the sympathetic nervous system, the surgically implanted barostimulator device117 and catheter-based renal denervation20,118.”

    From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [118]

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Authors
‡
Corresponding author
‡
Venue
The Lancet
Publisher
Elsevier BV
Published
2010-12
Volume
376
Issue
9756
Pages
1903-1909
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(10)62039-9
OpenAlex
W1583834060
Cited by
2,242
References
32
Citations by year
2026: 31 · 2025: 50 · 2024: 56 · 2023: 67 · 2022: 62 · 2021: 81 · 2020: 83 · 2019: 106 · 2018: 116 · 2017: 123 · 2016: 181 · 2015: 236 · 2014: 363 · 2013: 345 · 2012: 217
FWCI
147.84
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
  • Digital Access to Libraries (submittedVersion)
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 › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
Keywords
renal denervation, treatment-resistant hypertension, catheter-based renal denervation, blood pressure reduction, antihypertensive drugs, type 2 diabetes, renal sympathetic nerves, procedural safety, adverse events, hypertension pathogenesis, renal artery stenosis
MeSH terms
Aged, Antihypertensive Agents, Female, Humans, Hypertension, Kidney, Male, Middle Aged, Prospective Studies, Sympathectomy, Blood Pressure Monitoring, Ambulatory

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