Evidence map›Paper›PMID 24678939›Full record

Trial reportThe New England journal of medicine2014

A controlled trial of renal denervation for resistant hypertension.

Deepak L Bhatt, David E Kandzari, William W O'Neill, Ralph D'Agostino, John M Flack, Barry T Katzen, Martin B Leon, Minglei Liu, Laura Mauri, Manuela Negoita and 6 more

10 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 815 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
815citing papers in PubMed, 15 pooled it
212.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01418261 nacompletednot on this map

Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

TypeinterventionalSponsorMedtronic VascularRan2011 to 2017Enrolled535ConditionsUncontrolled HypertensionArmsRenal denervation (Symplicity Catheter System), Renal angiogram
NCT02243514 unknown statusnot on this map

Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases

TypeobservationalSponsorThe Second Affiliated Hospital of Chongqing Medical UniversityRan2014 to 2015Enrolled60ConditionsHypertension, Heart Failure
NCT02900729 phase3unknown statusnot on this mapstarted 2016, after this paper: background citation

A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension

TypeinterventionalSponsorShanghai WiseGain Medical Devices Co., Ltd.Ran2016 to 2018Enrolled254ConditionsHypertensionArmsRadiofrequency ablation catheter, Amlodipine, losartan potassium and hydrochlorothiazide
NCT05024630 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Atrial fIbrillation reCurrence Among Patients With Paroxysmal Atrial Fibrillation and Uncontrolled hypErtension: the DUAL-ICE Pilot Study

TypeinterventionalSponsorShanghai 10th People's HospitalRan2021 to 2023Enrolled30ConditionsParoxysmal Atrial Fibrillation, HypertensionArmsRenal artery cryoablation, Pulmonary vein cryoablation, Renal arteriography
NCT05421767 phase4recruitingnot on this mapstarted 2022, after this paper: background citation

National Tawan University Hospital

TypeinterventionalSponsorNational Taiwan University HospitalRan2022 to 2027Enrolled60ConditionsHypertensionArmsnerve stimulation guided renal denervation procedure
NCT05577208 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Cardiac Sympathetic Neuromodulation by Renal Denervation in Hypertrophic Cardiomyopathy (SNYPER Pilot Study)

TypeinterventionalSponsorAdolfo FontenlaRan2022 to 2024Enrolled20ConditionsHypertrophic CardiomyopathyArms"Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System)
NCT05743894 unknown statusnot on this mapstarted 2022, after this paper: background citation

Renal Nerve Simulation Guided Renal Sympathetic Denervation With Siymplicity Spyral Radiofrequency Catheter for Resistant Hypertension: a Feasibility Study.

Typeobservational_patient_registrySponsorChinese University of Hong KongRan2022 to 2023Enrolled10ConditionsHypertension, RenalArmsSymplicity Spyral RENAL DENERVATION (RDN) SYSTEMTM Livewire™ Reflexion™ Catheter
NCT05744986 unknown statusnot on this mapstarted 2022, after this paper: background citation

The Systemic Effects of Transcatheter Renal Artery Sympathetic Denervation Using a Second- Generation Radiofrequency Ablation Catheter: A Multicenter Observational Study.

Typeobservational_patient_registrySponsorChinese University of Hong KongRan2022 to 2025Enrolled100ConditionsHypertension, RenalArmsSYMPICITY Spyral RENAL DENERVATION (RDN) SYSTEMTM
NCT06208501 unknown statusnot on this mapstarted 2023, after this paper: background citation

The Predictive Role of Proteomics in Blood Pressure Response of Hypertensive Patients Undergoing Renal Denervation.

TypeobservationalSponsorHippocration General HospitalRan2023 to 2025Enrolled100ConditionsHypertension, Renal Denervation, ProteomicsArmsUrine sample for proteomic analysis, ABPM, OBPM
NCT07397260 naenrolling by invitationnot on this mapstarted 2026, after this paper: background citation

Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care

TypeinterventionalSponsorNorthwestern UniversityRan2026 to 2028Enrolled1,304ConditionsHypertension (HTN)ArmsSelf report of home measured blood pressure via patient EHR portal, Automated feedback about home blood pressure results, Automated Transmission of Remotely Measured Blood Pressure
3 · Its place in the literature

Who cites it

815 citing papers in PubMed, 15 syntheses or guidelines pooled it, 2,137 citations in OpenAlex.

  1. Cost-effectiveness of renal denervation: a systematic review and meta-analysis.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
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755 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 13 institutions in 1 country.

Deepak L BhattFrom Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B., L.M.), Boston University School of Public Health (R.D.), and Harvard Clinical Research Institute (R.D., L.M.) - all in Boston; Piedmont Heart Institute, Atlanta (D.E.K.); the Division of Cardiology, Henry Ford Hospital (W.W.O.), and Wayne State University and the Detroit Medical Center (J.M.F.) - all in Detroit; Baptist Cardiac and Vascular Institute, Miami (B.T.K.); New York Presbyterian Hospital, Columbia University Medical Center, and Cardiovascular Research Foundation, New York (M.B.L.); Medtronic CardioVascular, Santa Rosa, CA (M.L., M.N., S.A.C.); University of Alabama at Birmingham, Birmingham (S.O.); Prairie Heart Institute, Springfield, IL (K.R.-S.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (S.A.C., R.R.T.); and University of Chicago Medicine, Chicago (G.L.B.).
David E Kandzari
William W O'Neill
Ralph D'Agostino
John M Flack
Barry T Katzen
Martin B Leon
Minglei Liu
Laura Mauri
Manuela Negoita
Sidney A Cohen
Suzanne Oparil
Krishna Rocha-Singh
Raymond R Townsend
George L Bakris
SYMPLICITY HTN-3 Investigators
Medtronic (United States) · USUniversity of Pennsylvania · USBaptist Hospital of Miami · USBoston University · USBrigham and Women's Hospital · USCardiovascular Research Foundation · USHarvard University · USHenry Ford Hospital · USPiedmont Atlanta Hospital · USPrairie Vascular Institute · USUniversity of Alabama at Birmingham · USUniversity of Chicago · USWayne State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension.

methodsWe 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.

resultsA 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.

conclusionsThis 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.).

Indexed as

DenervationAgedBlood PressureFemaleHumansHypertensionIntention to Treat AnalysisMaleMiddle AgedPlacebosRadiographyRenal ArterySingle-Blind MethodTreatment FailurePlacebos

Identifiers

PMID24678939
OpenAlexW2133088349

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 4 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.