Evidence map›Paper›PMID 25400162›Full record

Trial reportEuropean heart journal2015

Predictors of blood pressure response in the SYMPLICITY HTN-3 trial.

David E Kandzari, Deepak L Bhatt, Sandeep Brar, Chandan M Devireddy, Murray Esler, Martin Fahy, John M Flack, Barry T Katzen, Janice Lea, David P Lee and 12 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 211 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
211citing papers in PubMed, 14 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.

NCT01418261 nacompletednot on this map

Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

TypeinterventionalSponsorMedtronic VascularRan2011 to 2017Enrolled535ConditionsUncontrolled HypertensionArmsRenal denervation (Symplicity Catheter System), Renal angiogram
NCT05743894 unknown statusnot on this mapstarted 2022, after this paper: background citation

Renal Nerve Simulation Guided Renal Sympathetic Denervation With Siymplicity Spyral Radiofrequency Catheter for Resistant Hypertension: a Feasibility Study.

Typeobservational_patient_registrySponsorChinese University of Hong KongRan2022 to 2023Enrolled10ConditionsHypertension, RenalArmsSymplicity Spyral RENAL DENERVATION (RDN) SYSTEMTM Livewire™ Reflexion™ Catheter
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
3 · Its place in the literature

Who cites it

211 citing papers in PubMed, 14 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Systematic review of renal denervation for the management of cardiac arrhythmias.Clinical research in cardiology : official journal of the German Cardiac Society · 2022
    Pooled it
  4. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. The state of renal sympathetic denervation for the management of patients with hypertension: A systematic review and meta-analysis.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2021
    Pooled it
  6. Pooled it
  7. Pooled it
  8. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019).Hypertension research : official journal of the Japanese Society of Hypertension · 2019
    Guideline
  9. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2017
    Pooled it
  10. Guideline
  11. Guideline
  12. Reductions of left ventricular mass and atrial size following renal denervation: a meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2016
    Pooled it
  13. Renal Denervation vs Pharmacotherapy for Resistant Hypertension: A Meta-Analysis.Journal of clinical hypertension (Greenwich, Conn.) · 2016
    Pooled it
  14. Pooled it
  15. Trial
  16. 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
  17. Trial
  18. Trial
  19. Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

David E KandzariPiedmont Heart Institute, Atlanta, GA, USA david.kandzari@piedmont.org.
Deepak L BhattBrigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA.
Sandeep BrarMedtronic, Inc., Santa Rosa, CA, USA.
Chandan M DevireddyEmory University School of Medicine, Atlanta, GA, USA.
Murray EslerBaker IDI Heart and Diabetes Institute, Monash University, Melbourne, Australia.
Martin FahyMedtronic, Inc., Santa Rosa, CA, USA.
John M FlackWayne State University and the Detroit Medical Center, Detroit, MI, USA.
Barry T KatzenBaptist Cardiac and Vascular Institute, Miami, FL, USA.
Janice LeaEmory University School of Medicine, Atlanta, GA, USA.
David P LeeStanford Hospital and Clinics, Palo Alto, CA, USA.
Martin B LeonNew York Presbyterian Hospital, Columbia University Medical Center and Cardiovascular Research Foundation, New York, NY, USA.
Adrian MaStanford Hospital and Clinics, Palo Alto, CA, USA.
Joseph MassaroHarvard Clinical Research Institute, Boston, MA, USA.
Laura MauriBrigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA Harvard Clinical Research Institute, Boston, MA, USA.
Suzanne OparilUniversity of Alabama at Birmingham, Birmingham, AL, USA.
William W O'NeillDivision of Cardiology, Henry Ford Hospital, Detroit, MI, USA.
Manesh R PatelDuke University Medical Center, Durham, NC, USA.
Krishna Rocha-SinghPrairie Heart Institute, Springfield, IL, USA.
Paul A SobotkaThe Ohio State University, Columbus, OH, USA.
Laura SvetkeyDuke University Medical Center, Durham, NC, USA.
Raymond R TownsendPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
George L BakrisThe University of Chicago Medicine, Chicago, IL, USA.

Funding

Re-Engineering Translational Research at the University of ChicagoUL1TR000430 · NCATS · UNIVERSITY OF CHICAGO · PI SOLWAY, JULIAN · 2012 to 2016
$20.2M
NCATS NIH HHS UL1 TR000430
6 · The paper itself

Abstract

aimsThe SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results. METHODS AND

resultsPatients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥ 180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group. Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham; -15.2 ± 23.5 vs. -8.6 ± 24.8 mmHg, respectively (P = 0.012). Greater reductions in office and ambulatory SBP, and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern.

conclusionsPost hoc analyses, although derived from limited patient cohorts, reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups. These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension. CLINICALTRIALS.GOV IDENTIFIER: NCT01418261.

Indexed as

AdultBlood PressureCatheter AblationChronic DiseaseFemaleHumansHypertensionKidneyMaleMiddle AgedSympathectomyTreatment OutcomeRenal denervationResistant hypertensionSYMPLICITY

Identifiers

PMID25400162
PMCPMC4301597

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.