A Controlled Trial of Renal Denervation for Resistant Hypertension
Abstract
BACKGROUND: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. METHODS: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. RESULTS: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. CONCLUSIONS: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).
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The first randomized, sham-controlled renal denervation trial, SYMPLICITY HTN-3, failed to prove superiority of renal denervation for blood pressure lowering compared with a sham control procedure.
“The first randomized, sham-controlled RDN trial, SYMPLICITY HTN-3, failed to prove superiority of RDN for BP lowering compared with a sham control procedure165.”
From Obesity, kidney dysfunction and hypertension: mechanistic links (2019) · cites this paper as [165]
SYMPLICITY HTN-3 was five times larger than the first two SYMPLICITY renal denervation trials and incorporated a blinded sham design.
“Five times larger than the first two SYMPLICITY renal denervation trials, and incorporating a blinded sham design”
From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [125]
In the SYMPLICITY HTN-3 trial, the primary efficacy endpoint was not reached.
“indicating that the primary efficacy endpoint had not been reached in the trial.”
From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [125]
The first sham-controlled prospective randomized study in renal ablation therapy, SYMPLICITY HTN-3, showed little to no effect of renal denervation therapy in a severely drug treatment-resistant population.
“The first sham-controlled prospective randomized study in the field of renal ablation therapy, SYMPLICITY HTN-3, showed little to no effect of renal denervation therapy in a severely drug treatment-resistant population.404”
From Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association (2018) · cites this paper as [404]
In a recent blinded, sham-controlled study (SYMPLICITY HTN-3), after 6 months, the blood pressure lowering effect of renal denervation was not significantly different from that observed in the sham group.
“Moreover, in a recent blinded, sham-controlled study (SYMPLICITY HTN-3), after 6 months, the blood pressure lowering effect of renal denervation was not significantly different from that observed in the sham group (30).”
From Obesity-Associated Hypertension: Recent Progress in Deciphering the Pathogenesis (2014) · cites this paper as [30]
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Renal denervation for the treatment of resistant hypertension: review and clinical perspective
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Self-citationCatheter-Based Renal Denervation Exacerbates Blood Pressure Fall During Hemorrhage
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Autonomic Blockade Improves Insulin Sensitivity in Obese Subjects
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Diagnosis and management of resistant hypertension: state of the art
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Renal denervation in patients with chronic kidney disease: current evidence and future perspectives
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Ambulatory arterial stiffness index as a predictor of blood pressure response to renal denervation*
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Home (Self) Monitoring of Blood Pressure in Clinical Trials
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- Authors
- Bhatt, D. L., Kandzari, D. E., O'Neill, W. W., D'Agostino, R., Flack, J. M., Katzen, B. T., Leon, M. B., Liu, M., Mauri, L., Negoita, M., Cohen, S. A., Oparil, S., Rocha-Singh, K., Townsend, R. R., & Bakris, G. L.
- Affiliations
- Boston University (US)
- Piedmont Atlanta Hospital (US)
- Wayne State University (US)
- Baptist Hospital of Miami (US)
- NewYork–Presbyterian Hospital (US)
- Brigham and Women's Hospital (US)
- University of Pennsylvania (US)
- University of Alabama at Birmingham (US)
- University of Chicago (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-04-10
- Volume
- 370
- Issue
- 15
- Pages
- 1393-1401
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2133088349
- Cited by
- 2,186
- References
- 27
- Citations by year
- 2026: 76 · 2025: 86 · 2024: 104 · 2023: 114 · 2022: 112 · 2021: 127 · 2020: 142 · 2019: 159 · 2018: 183 · 2017: 222 · 2016: 260 · 2015: 332 · 2014: 262 · 2013: 1
- FWCI
- 245.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- 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
- resistant hypertension, blood pressure reduction, ambulatory blood pressure, end-stage renal disease, embolic events, hypertensive crisis, renal artery stenosis
- MeSH terms
- Aged, Blood Pressure, Denervation, Female, Humans, Hypertension, Male, Middle Aged, Placebos, Radiography, Renal Artery, Single-Blind Method, Treatment Failure, Intention to Treat Analysis
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