Evidence map›Paper›PMID 32234534›Full record

Trial reportLancet (London, England)2020

Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial.

Michael Böhm, Kazuomi Kario, David E Kandzari, Felix Mahfoud, Michael A Weber, Roland E Schmieder, Konstantinos Tsioufis, Stuart Pocock, Dimitris Konstantinidis, James W Choi and 23 more

5 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 293 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
293citing papers in PubMed, 16 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.

NCT02439749 nacompletednot on this map

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)

TypeinterventionalSponsorMedtronic VascularRan2015 to 2023Enrolled366ConditionsHypertension, Vascular Diseases, Cardiovascular DiseasesArmsSymplicity Spyral™ multi-electrode renal denervation system, Sham Procedure
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
NCT05577208 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Cardiac Sympathetic Neuromodulation by Renal Denervation in Hypertrophic Cardiomyopathy (SNYPER Pilot Study)

TypeinterventionalSponsorAdolfo FontenlaRan2022 to 2024Enrolled20ConditionsHypertrophic CardiomyopathyArms"Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System)
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

293 citing papers in PubMed, 16 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Guideline
  13. Pooled it
  14. A European Renal Association (ERA) synopsis for nephrology practice of the 2023 European Society of Hypertension (ESH) Guidelines for the Management of Arterial Hypertension.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024
    Guideline
  15. Pooled it
  16. Pooled it
  17. Trial
  18. Trial
  19. Two-year nighttime blood pressure changes after radiofrequency renal denervation: pooled results from the SPYRAL HTN trials.Hypertension research : official journal of the Japanese Society of Hypertension · 2025
    Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors.

Michael BöhmKlinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany. Electronic address: michael.boehm@uks.eu.
Kazuomi KarioJichi Medical University School of Medicine, Tochigi, Japan.
David E KandzariPiedmont Heart Institute, Atlanta, GA, USA.
Felix MahfoudKlinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA.
Michael A WeberSUNY Downstate College of Medicine, Brooklyn, NY, USA.
Roland E SchmiederUniversitätsklinikum Erlangen, Erlangen, Germany.
Konstantinos TsioufisNational and Kapodistrian University of Athens, Hippocratio Hospital, Athens, Greece.
Stuart PocockLondon School of Hygiene & Tropical Medicine, London, UK.
Dimitris KonstantinidisNational and Kapodistrian University of Athens, Hippocratio Hospital, Athens, Greece.
James W ChoiBaylor Scott and White Heart and Vascular Hospital, Dallas, TX, USA.
Cara EastBaylor Scott and White Heart and Vascular Hospital, Dallas, TX, USA.
David P LeeStanford Hospital and Clinics, Stanford, CA, USA.
Adrian MaStanford Hospital and Clinics, Stanford, CA, USA.
Sebastian EwenKlinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany.
Debbie L CohenPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Robert WilenskyPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Chandan M DevireddyEmory University School of Medicine, Atlanta, GA, USA.
Janice LeaEmory University School of Medicine, Atlanta, GA, USA.
Axel SchmidUniversitätsklinikum Erlangen, Erlangen, Germany.
Joachim WeilSana Cardiomed Heart Center, LÜbeck, Germany.
Tolga AgdirliogluSana Cardiomed Heart Center, LÜbeck, Germany.
Denise ReedusPiedmont Heart Institute, Atlanta, GA, USA.
Brian K JeffersonTriStar Centennial Medical Center, Nashville, TN, USA.
David ReyesTriStar Centennial Medical Center, Nashville, TN, USA.
Richard D'SouzaThe Royal Devon and Exeter Hospital, Exeter, UK.
Andrew S P SharpUniversity Hospital of Wales, Cardiff, UK; University of Exeter, Exeter, UK.
Faisal SharifGalway University Hospitals and National University of Ireland Galway, Galway, Ireland.
Martin FahyMedtronic, Santa Rosa, CA, USA.
Vanessa DeBruinMedtronic, Santa Rosa, CA, USA.
Sidney A CohenPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Medtronic, Santa Rosa, CA, USA.
Sandeep BrarMedtronic, Santa Rosa, CA, USA.
Raymond R TownsendPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
SPYRAL HTN-OFF MED Pivotal Investigators

Funding

Dissemination and Implementation Science in Cardiovascular Outcomes (DISCO)K12HL138030 · NHLBI · DUKE UNIVERSITY · PI BOSWORTH, HAYDEN B · 2017 to 2021
$3.9M
NHLBI NIH HHS K12 HL138030
6 · The paper itself

Abstract

backgroundCatheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications.

methodsIn this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749.

findingsFrom June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3·9 mm Hg (Bayesian 95% credible interval -6·2 to -1·6) and for office systolic blood pressure the difference was -6·5 mm Hg (-9·6 to -3·5). No major device-related or procedural-related safety events occurred up to 3 months.

interpretationSPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications.

fundingMedtronic.

Indexed as

AdultAntihypertensive AgentsAustraliaAustriaBayes TheoremBlood PressureCanadaFemaleGermanyGreeceHumansHypertensionIrelandJapanKidneyMaleAntihypertensive AgentsPlacebos

Identifiers

PMID32234534

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.