Evidence map›Paper›PMID 29895590›Full record

Trial reportJournal of the American Heart Association2018

Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success.

Manish Saxena, Tariq Shour, Mussadiq Shah, Christopher B Wolff, Peter O O Julu, Vikas Kapil, David J Collier, Fu Liang Ng, Ajay Gupta, Armida Balawon and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02029885 (Wave IV Study), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 17% 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.

NCT02029885 naunknown statusnot on this map

Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

TypeinterventionalSponsorKona Medical Inc.Ran2014 to 2018Enrolled132ConditionsHypertensionArmsInvestigational Therapy (Surround Sound), Sham Control
3 · Its place in the literature

Who cites it

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

  1. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Device-Based Therapy for Resistant Hypertension: An Up-to-Date Review.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2022
    Review
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 2 countries.

Manish SaxenaBarts BP Centre of Excellence, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom m.saxena@qmul.ac.uk.
Tariq ShourBarts BP Centre of Excellence, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom.
Mussadiq ShahWilliam Harvey Research Institute, Centre for Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University London, London, United Kingdom.
Christopher B WolffWilliam Harvey Research Institute, Centre for Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University London, London, United Kingdom.
Peter O O JuluWilliam Harvey Research Institute, Centre for Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University London, London, United Kingdom.
Vikas KapilBarts BP Centre of Excellence, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom.
David J CollierWilliam Harvey Research Institute, Centre for Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University London, London, United Kingdom.
Fu Liang NgBarts BP Centre of Excellence, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom.
Ajay GuptaBarts BP Centre of Excellence, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom.
Armida BalawonWilliam Harvey Research Institute, Centre for Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University London, London, United Kingdom.
Jane PhebyWilliam Harvey Research Institute, Centre for Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University London, London, United Kingdom.
Anne ZakWilliam Harvey Research Institute, Centre for Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University London, London, United Kingdom.
Gurvinder RullBarts BP Centre of Excellence, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom.
Benjamin O'BrienWilliam Harvey Research Institute, Centre for Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, Queen Mary University London, London, United Kingdom.
Roland E SchmiederDepartment of Nephrology and Hypertension, University Hospital, University of Erlangen/Nuremberg, Erlangen, Germany.
Melvin D LoboBarts BP Centre of Excellence, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom.
William Harvey Research Institute · GBSt Bartholomew's Hospital · GBQueen Mary University of London · GBFriedrich-Alexander-Universität Erlangen-Nürnberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRenal denervation has no validated marker of procedural success. We hypothesized that successful renal denervation would reduce renal sympathetic nerve signaling demonstrated by attenuation of α-1-adrenoceptor-mediated autotransfusion during the Valsalva maneuver. METHODS AND

resultsIn this substudy of the Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension, we enrolled 23 subjects with resistant hypertension. They were randomized either to bilateral renal denervation using therapeutic levels of ultrasound energy (n=12) or sham application of diagnostic ultrasound (n=11). Within-group changes in autonomic parameters, office and ambulatory blood pressure were compared between baseline and 6 months in a double-blind manner. There was significant office blood pressure reduction in both treatment (16.1±27.3 mm Hg,

conclusionsBlood pressure reduction per se is not necessarily a marker of successful renal nerve ablation. Reduction in splanchnic autotransfusion following renal denervation has not been previously demonstrated and denotes attenuation of (renal) sympathetic efferent activity and could serve as a marker of procedural success. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT02029885.

Indexed as

Splanchnic CirculationUltrasonic Surgical ProceduresValsalva ManeuverAgedAntihypertensive AgentsArterial PressureDouble-Blind MethodDrug ResistanceFemaleHeart RateHumansHypertensionKidneyMaleMiddle AgedPredictive Value of TestsAntihypertensive Agentsautonomic functionblood pressurehypertensionrenal denervationsympathetic nervous systemultrasoundValsalva maneuver

Identifiers

PMID29895590
PMCPMC6220552
OpenAlexW2808201078

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.