Evidence map›Paper›PMID 27228432›Full record

Trial reportJournal of hypertension2016

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial.

Ole N Mathiassen, Henrik Vase, Jesper N Bech, Kent L Christensen, Niels H Buus, Anne P Schroeder, Ole Lederballe, Hans Rickers, Ulla Kampmann, Per L Poulsen and 10 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of hypertension, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 16 pooled it
11.9field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 16 syntheses or guidelines pooled it, 139 citations in OpenAlex.

  1. Pooled it
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  6. Guideline
  7. Efficacy and Safety of Radiofrequency-Based Renal Denervation on Resistant Hypertensive Patients: A Systematic Review and Meta-analysis.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2024
    Pooled it
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  10. Randomized Blinded Placebo-Controlled Trials of Renal Sympathetic Denervation for Hypertension: A Meta-Analysis.Cardiovascular revascularization medicine : including molecular interventions · 2022
    Pooled it
  11. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
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  15. Effectiveness of Renal Denervation in Resistant Hypertension: A Meta-Analysis of 11 Controlled Studies.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2018
    Pooled it
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  17. 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
  18. Trial
  19. Kidney Denervation: Latest Breakthroughs and Insights.Clinical journal of the American Society of Nephrology : CJASN · 2026
    Review
  20. Overcoming variable response in renal denervation: Key strategies for reliable clinical implementation.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 1 institution in 1 country.

Ole N MathiassenaDepartment of Cardiology, Aarhus University Hospital, Skejby bUniversity Clinic in Nephrology and Hypertension, Holstebro Hospital, Hospital Jutland West, Holstebro cDepartment of Nephrology, Aarhus University Hospital, Skejby dDepartment of Cardiology, Viborg Hospital, Viborg eDepartment of Cardiology, Randers Hospital, Randers fDepartment of Endocrinology, Aarhus University Hospital, NBG, Skejby gDepartment of Internal Medicine, Silkeborg Hospital, Silkeborg hDepartment of Radiology, Aarhus University Hospital, Skejby, Denmark.
Henrik Vase
Jesper N Bech
Kent L Christensen
Niels H Buus
Anne P Schroeder
Ole Lederballe
Hans Rickers
Ulla Kampmann
Per L Poulsen
Klavs W Hansen
Hans E Btker
Christian D Peters
Morten Engholm
Jannik B Bertelsen
Jens F Lassen
Sten Langfeldt
Gratien Andersen
Erling B Pedersen
Anne Kaltoft
Aarhus University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRenal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP.

methodWe conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA).

resultsWe randomized 69 patients with treatment-resistant hypertension to RDN (n = 36) or SHAM (n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ± 12 mmHg (RDN) and 159 ± 14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2 ± 18.8 mmHg (RDN) vs. -6.0 ± 13.5 mmHg (SHAM)] and at 6 months [-6.1 ± 18.9 mmHg (RDN) vs. -4.3 ± 15.1 mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8 ± 2.7 (RDN) vs. 7.0 ± 2.5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial.

conclusionFurther, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

Indexed as

Blood PressureSympathectomyAgedAntihypertensive AgentsBlood Pressure Monitoring, AmbulatoryCatheter AblationCoronary VasospasmDouble-Blind MethodEssential HypertensionFemaleHumansHypertensionKidneyMaleMiddle AgedAntihypertensive Agents

Identifiers

PMID27228432
PMCPMC4933576
OpenAlexW2397519623

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.