Evidence mapPaperPMID 38314554Full record

Trial reportHypertension (Dallas, Tex. : 1979)2024

Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED.

Raymond R Townsend, Keith C Ferdinand, David E Kandzari, Kazuomi Kario, Felix Mahfoud, Michael A Weber, Roland E Schmieder, Stuart Pocock, Konstantinos Tsioufis, Shukri David and 10 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Hypertension (Dallas, Tex. : 1979), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02439775 (Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
11.7field-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.

NCT02439775 nacompletednot on this map

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

TypeinterventionalSponsorMedtronic VascularRan2015 to 2025Enrolled337ConditionsHypertension, Vascular Diseases, Cardiovascular DiseasesArmsSymplicity Spyral™ multi-electrode renal denervation system, Sham Procedure
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
  2. Fluctuations in adherence to antihypertensive medication and cardiovascular outcomes: a secondary analysis of the SPRINT trial.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Trial
  3. Kidney Denervation: Latest Breakthroughs and Insights.Clinical journal of the American Society of Nephrology : CJASN · 2026
    Review
  4. Review
  5. Review
  6. Patient Selection and Renal Denervation.Current hypertension reports · 2026
    Review
  7. Article
  8. Review
  9. Renal denervation for hypertension.Nature reviews. Cardiology · 2025
    Review
  10. Hypertension: a lymphatic disease?Clinical science (London, England : 1979) · 2025
    Review
  11. In these cases, I treat hypertension with renal ablation.European heart journal supplements : journal of the European Society of Cardiology · 2025
    Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. What are the ideal metrics for assessing the quality of long-term stabilized "perfect" 24-h BP control after renal denervation?Hypertension research : official journal of the Japanese Society of Hypertension · 2024
    Review
  19. Renal denervation up-to-date 2024: evidence and perspectives in Japan.Hypertension research : official journal of the Japanese Society of Hypertension · 2024
    Article
  20. 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

20 authors at 15 institutions in 7 countries.

Raymond R TownsendPereleman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.).
Keith C FerdinandTulane University School of Medicine, New Orleans, LA (K.C.F.).ORCID 0000-0003-3338-4410
David E KandzariPiedmont Heart Institute, Atlanta, GA (D.E.K.).ORCID 0000-0002-0868-6655
Kazuomi KarioDepartment of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.).ORCID 0000-0002-8251-4480
Felix MahfoudUniversitätsklinikum des Saarlandes, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin, Saarland University, Homburg, Germany (F.M., M.B.).ORCID 0000-0002-4425-549X
Michael A WeberSUNY Downstate College of Medicine, New York, NY (M.A.W.).ORCID 0000-0002-8504-0831
Roland E SchmiederUniversity Hospital Erlangen, Germany (R.E.S.).ORCID 0000-0003-2356-5883
Stuart PocockLondon School of Hygiene & Tropical Medicine, United Kingdom (S.P.).ORCID 0000-0003-2212-4007
Konstantinos TsioufisNational and Kapodistrian University of Athens Hippocratio Hospital, Greece (K.T.).ORCID 0000-0002-7636-6725
Shukri DavidAscension Providence Hospital, Southfield, MI (S.D., S.S.).ORCID 0000-0002-9132-7425
Susan SteigerwaltAscension Providence Hospital, Southfield, MI (S.D., S.S.).
Antony WaltonThe Alfred Hospital, Melbourne, Australia (A.W., I.H.).ORCID 0000-0002-9173-5904
Ingrid HopperThe Alfred Hospital, Melbourne, Australia (A.W., I.H.).ORCID 0000-0002-8805-370X
Barry BertoletNorth Mississippi Health Services, Tupelo (B.B.).ORCID 0000-0003-4502-7074
Faisal SharifUniversity of Galway Ireland (F.S.).ORCID 0000-0003-0086-4864
Karl FenglerHeart Center of Leipzig, Germany (K.F.).ORCID 0000-0003-0611-7376
Martin FahyMedtronic, Santa Rosa, CA (M.F., D.A.H., S.B.).
Douglas A HettrickMedtronic, Santa Rosa, CA (M.F., D.A.H., S.B.).ORCID 0000-0002-8957-7740
Sandeep BrarMedtronic, Santa Rosa, CA (M.F., D.A.H., S.B.).
Michael BöhmUniversitätsklinikum des Saarlandes, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin, Saarland University, Homburg, Germany (F.M., M.B.).
Medtronic (Ireland) · IEAscension Providence Hospital · USThe Alfred Hospital · AUUniversitätsklinikum des Saarlandes · DEHippocration General Hospital · GRJichi Medical University · JPLeipzig Heart Institute · DENorth Mississippi Medical Center · USOllscoil na Gaillimhe – University of Galway · IEPiedmont Atlanta Hospital · USSUNY Downstate Health Sciences University · USTulane University · USUniversitätsklinikum Erlangen · DEUniversity of London · GBUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe SPYRAL HTN-ON MED (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)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations.

methodsThe multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans.

resultsChanges in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months (

conclusionsPatients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775.

Indexed as

Antihypertensive AgentsHypertensionBlood PressureDenervationHumansKidneySympathectomyTreatment OutcomeAntihypertensive Agentsantihypertensive agentsBlack or African Americanblood pressurehypertensionrenal denervation

Identifiers

PMID38314554
PMCPMC11025607
OpenAlexW4391534401

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.