Evidence map›Paper›PMID 22573363›Full record

Trial reportClinical cardiology2012

Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial.

David E Kandzari, Deepak L Bhatt, Paul A Sobotka, William W O'Neill, Murray Esler, John M Flack, Barry T Katzen, Martin B Leon, Joseph M Massaro, Manuela Negoita and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cardiology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01932450 (A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease), which is not on this map. Cited by 93 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 3 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.

NCT01932450 phase2unknown statusnot on this mapstarted 2013, after this paper: background citation

A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease

TypeinterventionalSponsorMei changlinRan2013 to 2015Enrolled100ConditionsAutosomal Dominant Polycystic Kidney Disease, HypertensionArmsrenal sympathetic denervation, antihypertensive drugs
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Renal Sympathetic Denervation for Hypertension.Kidney international reports · 2022
    Review
  15. Review
  16. Article
  17. Article
  18. Long-Term Effects of Renal Artery Denervation.Medicina (Kaunas, Lithuania) · 2021
    Article
  19. Review
  20. Review

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

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.

David E KandzariPiedmont Heart Institute, Atlanta, GA, USA. david.kandzari@piedmont.org
Deepak L Bhatt
Paul A Sobotka
William W O'Neill
Murray Esler
John M Flack
Barry T Katzen
Martin B Leon
Joseph M Massaro
Manuela Negoita
Suzanne Oparil
Krishna Rocha-Singh
Craig Straley
Raymond R Townsend
George Bakris

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hypertension represents a significant global public health concern, contributing to vascular and renal morbidity, cardiovascular mortality, and economic burden. The opportunity to influence clinical outcomes through hypertension management is therefore paramount. Despite adherence to multiple available medical therapies, a significant proportion of patients have persistent blood pressure elevation, a condition termed resistant hypertension. Recent recognition of the importance of the renal sympathetic and somatic nerves in modulating blood pressure and the development of a novel procedure that selectively removes these contributors to resistant hypertension represents an opportunity to provide clinically meaningful benefit across wide and varied patient populations. Early clinical evaluation with catheter-based, selective renal sympathetic denervation in patients with resistant hypertension has mechanistically correlated sympathetic efferent denervation with decreased renal norepinephrine spillover and renin activity, increased renal plasma flow, and has demonstrated clinically significant, sustained reductions in blood pressure. The SYMPLICITY HTN-3 Trial is a pivotal study designed as a prospective, randomized, masked procedure, single-blind trial evaluating the safety and effectiveness of catheter-based bilateral renal denervation for the treatment of uncontrolled hypertension despite compliance with at least 3 antihypertensive medications of different classes (at least one of which is a diuretic) at maximal tolerable doses. The primary effectiveness endpoint is measured as the change in office-based systolic blood pressure from baseline to 6 months. This manuscript describes the design and methodology of a regulatory trial of selective renal denervation for the treatment of hypertension among patients who have failed pharmacologic therapy.

Indexed as

AdultAgedBlood PressureBlood Pressure Monitoring, AmbulatoryCathetersHumansHypertensionKidneyMiddle AgedRenal ArteryResearch DesignSingle-Blind MethodSympathectomyTreatment OutcomeYoung Adult

Identifiers

PMID22573363
PMCPMC6652693

What OpenQuestion holds

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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.