Evidence map›Paper›PMID 37427416›Full record

Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2023

Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications.

Atul Pathak, Ulrike M Rudolph, Manish Saxena, Thomas Zeller, Jochen Müller-Ehmsen, Erik Lipsic, Roland E Schmieder, Horst Sievert, Marcel Halbach, Faisal Sharif and 5 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03503773 (A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications), which is not on this map. Cited by 33 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 6 pooled it
11.0field-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.

NCT03503773 phase2completednot on this map

A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications

TypeinterventionalSponsorAblative Solutions, Inc.Ran2018 to 2024Enrolled350ConditionsHypertension, Hypertension,EssentialArmsAlcohol, Sham control
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 6 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Review
  8. Kidney Denervation: Latest Breakthroughs and Insights.Clinical journal of the American Society of Nephrology : CJASN · 2026
    Review
  9. Review
  10. Overcoming variable response in renal denervation: Key strategies for reliable clinical implementation.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Review
  11. Review
  12. Review
  13. Review
  14. The Japanese Society of Hypertension Guidelines for the management of elevated blood pressure and hypertension 2025 (JSH2025).Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Article
  15. Review
  16. Review
  17. Renal denervation for hypertension.Nature reviews. Cardiology · 2025
    Review
  18. Review
  19. Article
  20. The Role of Renal Denervation in HFpEF.Journal of clinical medicine · 2025
    Review
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

15 authors at 7 institutions in 4 countries.

Atul PathakDepartment of Cardiovascular Medicine, Princess Grace Hospital, Principality of Monaco.
Ulrike M RudolphKlinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Universität Leipzig, Leipzig, Germany.
Manish SaxenaBarts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK.
Thomas ZellerUniversitäts-Herzzentrum Bad Krozingen, Bad Krozingen, Germany.
Jochen Müller-EhmsenAsklepios Klinik Altona, Hamburg, Germany.
Erik LipsicDepartment of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.
Roland E SchmiederUniversitätsklinikum Erlangen, Erlangen, Germany and Friedrich Alexander University Erlangen/Nürnberg, Erlangen, Germany.
Horst SievertCardioVasculäres Centrum (CVC) Frankfurt, Frankfurt, Germany.
Marcel HalbachUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Clinic III for Internal Medicine, Cologne, Germany and Herzzentrum der Uniklinik Koln, Koln, Germany.
Faisal SharifSaolta University Healthcare Group, University Hospital Galway, Galway, Ireland.
Helen PariseYale University School of Medicine, New Haven, CT, USA.
Tim A FischellAblative Solutions Inc., Wakefield, MA, USA.
Michael A WeberDivision of Cardiovascular Medicine, State University of New York (SUNY), New York, NY, USA.
David E KandzariDepartment of Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA, USA.
Felix MahfoudDepartment of Internal Medicine III - cardiology, angiology and internal intensive care medicine, Saarland University Medical Center, Homburg, Germany.
Asklepios Klinik Altona · DEMassachusetts Institute of Technology · USPiedmont Atlanta Hospital · USUniversitäts-Herzzentrum Freiburg-Bad Krozingen · DEUniversity Medical Center Groningen · NLWilliam Harvey Research Institute · GBYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUltrasound and radiofrequency renal denervation (RDN) have been shown to safely lower blood pressure (BP) in hypertension.

aimsThe TARGET BP OFF-MED trial investigated the efficacy and safety of alcohol-mediated renal denervation (RDN) in the absence of antihypertensive medications.

methodsThis randomised, blinded, sham-controlled trial was conducted in 25 centres in Europe and the USA. Patients with a 24-hour systolic BP of 135-170 mmHg, an office systolic BP 140-180 mmHg and diastolic BP ≥90 mmHg on 0-2 antihypertensive medications were enrolled. The primary efficacy endpoint was the change in mean 24-hour systolic BP at 8 weeks. Safety endpoints included major adverse events up to 30 days.

resultsA total of 106 patients were randomised; the baseline mean office BP following medication washout was 159.4/100.4±10.9/7.0 mmHg (RDN) and 160.1/98.3±11.0/6.1 mmHg (sham), respectively. At 8 weeks post-procedure, the mean (±standard deviation) 24-hour systolic BP change was â2.9±7.4 mmHg (p=0.009) versus â1.4±8.6 mmHg (p=0.25) in the RDN and sham groups, respectively (mean between-group difference: 1.5 mmHg; p=0.27). There were no differences in safety events between groups. After 12 months of blinded follow-up, with medication escalation, patients achieved similar office systolic BP (RDN: 147.9±18.5 mmHg; sham: 147.8±15.1 mmHg; p=0.68) with a significantly lower medication burden in the RDN group (mean daily defined dose: 1.5±1.5 vs 2.3±1.7; p=0.017).

conclusionsIn this trial, alcohol-mediated RDN was delivered safely but was not associated with significant BP differences between groups. Medication burden was lower in the RDN group up to 12 months.

Indexed as

Antihypertensive AgentsHypertensionBlood PressureBlood Pressure Monitoring, AmbulatoryDenervationEthanolHumansKidneySympathectomyTreatment OutcomeAntihypertensive AgentsEthanol

Identifiers

PMID37427416
PMCPMC10493775
OpenAlexW4383711283

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.