Evidence map›Paper›PMID 21093036›Full record

Trial reportLancet (London, England)2010

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

Symplicity HTN-2 Investigators, Murray D Esler, Henry Krum, Paul A Sobotka, Markus P Schlaich, Roland E Schmieder, Michael Böhm

11 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 11 registered trials, which are not on this map. Cited by 728 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
728citing papers in PubMed, 14 pooled it
–field-weighted citation impact
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.

NCT00888433 nacompletednot on this map

Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

TypeinterventionalSponsorMedtronic VascularRan2009 to 2015Enrolled106ConditionsUncontrolled HypertensionArmsRenal Denervation (Symplicity® Renal Denervation System)
NCT01427049 completednot on this mapstarted 2011, after this paper: background citation

The Evaluation of Renal Denervation on Several Biological Variables in Patients With Uncontrolled Hypertension. An Observational Feasibility Study.

TypeobservationalSponsorUMC UtrechtRan2011 to 2014Enrolled54ConditionsHypertensionArmsrenal denervation
NCT01628198 naterminatednot on this mapstarted 2011, after this paper: background citation

Impact of Renal SympAthetic DenerVation on Chronic HypErtension

TypeinterventionalSponsorVivek ReddyRan2011 to 2015Enrolled38ConditionsUncontrolled HypertensionArmsCelcius Thermacool Catheter or Chilli II Cooled Ablation Catheter
NCT01689415 terminatednot on this mapstarted 2012, after this paper: background citation

Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension

TypeobservationalSponsorBispebjerg HospitalRan2012 to 2014Enrolled25ConditionsStroke, Hypertension
NCT01870310 naunknown statusnot on this mapstarted 2012, after this paper: background citation

Long Term Study on the Possible Beneficial Effects of Catheterised Renal Denervation in Patients With Heart Failure and Left Ventricular Systolic Dysfunction Who Are Already on Standard Medical Therapy.

TypeinterventionalSponsorUniversity Hospital OlomoucRan2012 to 2016Enrolled50ConditionsHeart FailureArmsCatheterised renal denervation
NCT01875809 unknown statusnot on this mapstarted 2013, after this paper: background citation

Impact of Patient-specific and Procedural Characteristics Like Catecholamine Spill-over on the Long-term Outcome After Renal Denervation and EP Ablation

TypeobservationalSponsorUniversity of Witten/HerdeckeRan2013Enrolled80ConditionsHypertension
NCT01932450 phase2unknown statusnot on this mapstarted 2013, after this paper: background citation

A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease

TypeinterventionalSponsorMei changlinRan2013 to 2015Enrolled100ConditionsAutosomal Dominant Polycystic Kidney Disease, HypertensionArmsrenal sympathetic denervation, antihypertensive drugs
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
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
3 · Its place in the literature

Who cites it

728 citing papers in PubMed, 14 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Systematic review of renal denervation for the management of cardiac arrhythmias.Clinical research in cardiology : official journal of the German Cardiac Society · 2022
    Pooled it
  9. Pooled it
  10. Pooled it
  11. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  12. The state of renal sympathetic denervation for the management of patients with hypertension: A systematic review and meta-analysis.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2021
    Pooled it
  13. Pooled it
  14. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019).Hypertension research : official journal of the Japanese Society of Hypertension · 2019
    Guideline
  15. Trial
  16. Trial
  17. Durability of blood pressure reduction after ultrasound renal denervation: three-year follow-up of the treatment arm of the randomised RADIANCE-HTN SOLO trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Trial
  18. Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial.Hypertension research : official journal of the Japanese Society of Hypertension · 2022
    Trial
  19. Trial
  20. Trial

668 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Symplicity HTN-2 InvestigatorsBaker IDI Heart and Diabetes Institute, PO Box 6492, St Kilda Road, Central Melbourne, VIC 8008, Australia. murray.esler@bakeridi.edu.au
Murray D Esler
Henry Krum
Paul A Sobotka
Markus P Schlaich
Roland E Schmieder
Michael Böhm

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundActivation 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.

methodsIn 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.

findings106 (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.

interpretationCatheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients.

fundingArdian.

Indexed as

SympathectomyAgedAntihypertensive AgentsBlood Pressure Monitoring, AmbulatoryFemaleHumansHypertensionKidneyMaleMiddle AgedProspective StudiesAntihypertensive Agents

Identifiers

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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.