Evidence map›Paper›PMID 19332353›Full record

ArticleLancet (London, England)2009

Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study.

Henry Krum, Markus Schlaich, Rob Whitbourn, Paul A Sobotka, Jerzy Sadowski, Krzysztof Bartus, Boguslaw Kapelak, Anthony Walton, Horst Sievert, Suku Thambar and 2 more

9 registry-linked trialsAbstract readControlled Clinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Article in Lancet (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 750 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
750citing papers in PubMed, 16 pooled it
72.7field-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.

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
NCT01584700 phase1completednot on this mapstarted 2011, after this paper: background citation

Renal Artery Denervation in Chronic Heart Failure- Pilot

TypeinterventionalSponsorImperial College LondonRan2011 to 2012Enrolled7ConditionsCongestive Cardiac FailureArmsRenal Artery Denervation
NCT01628172 nacompletednot on this mapstarted 2011, after this paper: background citation

Renal Sympathetic Denervation for the Management of Chronic Hypertension

TypeinterventionalSponsorVivek ReddyRan2011 to 2014Enrolled96ConditionsUncontrolled HypertensionArmsBiosense Webster Celcius Thermacool catheter
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
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
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
NCT07108829 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

First-in-Man Clinical Study to Evaluate the Safety and Efficacy of Renal Artery Radiofrequency Ablation Clamp, Radiofrequency Ablation Generator for the Adjunctive Treatment of Refractory Hypertension and Drug-Intolerant Hypertension

TypeinterventionalSponsorHenan Institute of Cardiovascular EpidemiologyRan2025 to 2026Enrolled10ConditionsRefractory Hypertension or Drug-intolerant HypertensionArmsRenal Artery Radiofrequency Ablation Clamp
3 · Its place in the literature

Who cites it

750 citing papers in PubMed, 16 syntheses or guidelines pooled it, 2,096 citations in OpenAlex.

  1. Pooled it
  2. Guideline
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  5. Guideline
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  11. 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
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  14. 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
  15. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2020
    Pooled it
  16. Pooled it
  17. Efficacy and safety of a modified ozone-mediated neurolysis in treatment for patients with resistant hypertension.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Trial
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  20. 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

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 4 countries.

Henry KrumCentre of Cardiovascular Research and Education in Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Markus Schlaich
Rob Whitbourn
Paul A Sobotka
Jerzy Sadowski
Krzysztof Bartus
Boguslaw Kapelak
Anthony Walton
Horst Sievert
Suku Thambar
William T Abraham
Murray Esler
Jagiellonian University · PLBaker Heart and Diabetes Institute · AUThe Alfred Hospital · AUThe Ohio State University · USCardiovascular Center Frankfurt · DEJohn Hunter Hospital · AUSt Vincent's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRenal sympathetic hyperactivity is associated with hypertension and its progression, chronic kidney disease, and heart failure. We did a proof-of-principle trial of therapeutic renal sympathetic denervation in patients with resistant hypertension (ie, systolic blood pressure >/=160 mm Hg on three or more antihypertensive medications, including a diuretic) to assess safety and blood-pressure reduction effectiveness.

methodsWe enrolled 50 patients at five Australian and European centres; 5 patients were excluded for anatomical reasons (mainly on the basis of dual renal artery systems). Patients received percutaneous radiofrequency catheter-based treatment between June, 2007, and November, 2008, with subsequent follow-up to 1 year. We assessed the effectiveness of renal sympathetic denervation with renal noradrenaline spillover in a subgroup of patients. Primary endpoints were office blood pressure and safety data before and at 1, 3, 6, 9, and 12 months after procedure. Renal angiography was done before, immediately after, and 14-30 days after procedure, and magnetic resonance angiogram 6 months after procedure. We assessed blood-pressure lowering effectiveness by repeated measures ANOVA. This study is registered in Australia and Europe with ClinicalTrials.gov, numbers NCT 00483808 and NCT 00664638.

findingsIn treated patients, baseline mean office blood pressure was 177/101 mm Hg (SD 20/15), (mean 4.7 antihypertensive medications); estimated glomerular filtration rate was 81 mL/min/1.73m(2) (SD 23); and mean reduction in renal noradrenaline spillover was 47% (95% CI 28-65%). Office blood pressures after procedure were reduced by -14/-10, -21/-10, -22/-11, -24/-11, and -27/-17 mm Hg at 1, 3, 6, 9, and 12 months, respectively. In the five non-treated patients, mean rise in office blood pressure was +3/-2, +2/+3, +14/+9, and +26/+17 mm Hg at 1, 3, 6, and 9 months, respectively. One intraprocedural renal artery dissection occurred before radiofrequency energy delivery, without further sequelae. There were no other renovascular complications.

interpretationCatheter-based renal denervation causes substantial and sustained blood-pressure reduction, without serious adverse events, in patients with resistant hypertension. Prospective randomised clinical trials are needed to investigate the usefulness of this procedure in the management of this condition.

Indexed as

AdultAgedAnalysis of VarianceAntihypertensive AgentsBlood Pressure Monitoring, AmbulatoryCatheter AblationDiureticsFemaleFollow-Up StudiesGlomerular Filtration RateHumansHypertensionMagnetic Resonance ImagingMaleMiddle AgedNorepinephrineAntihypertensive AgentsDiureticsNorepinephrine

Identifiers

PMID19332353
OpenAlexW2115461708

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 3 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.