Evidence map›Paper›PMID 32740754›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2021

Effect of renal denervation in attenuating the stress of morning surge in blood pressure: post-hoc analysis from the SPYRAL HTN-ON MED trial.

Kazuomi Kario, Michael A Weber, Michael Böhm, Raymond R Townsend, Felix Mahfoud, Roland E Schmieder, Konstantinos Tsioufis, Sidney A Cohen, Martin Fahy, David E Kandzari

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2021. 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 17 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 6 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.

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

17 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Pooled it
  6. Renal denervation for resistant hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  7. Review
  8. Review
  9. Social jet lag and morning blood pressure surge-central nervous system matters?Hypertension research : official journal of the Japanese Society of Hypertension · 2023
    Article
  10. Article
  11. Article
  12. Observational
  13. 2022 Malaysian Working Group Consensus Statement on Renal Denervation for management of arterial hypertension.Hypertension research : official journal of the Japanese Society of Hypertension · 2022
    Article
  14. Review
  15. Article
  16. Article
  17. Renal arteries denervation: from the treatment of resistant hypertension to the treatment of atrial fibrillation.European heart journal supplements : journal of the European Society of Cardiology · 2021
    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

10 authors.

Kazuomi KarioDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. kkario@jichi.ac.jp.ORCID http://orcid.org/0000-0002-8251-4480
Michael A WeberDepartment of Medicine, SUNY Downstate College of Medicine, Brooklyn, NY, USA.
Michael BöhmDepartment of Internal Medicine, Klinik für Innere Medizin III, Universitätsklinikum Des Saarlandes, Saarland University, Homburg/Saar, Germany.
Raymond R TownsendDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Felix MahfoudDepartment of Internal Medicine, Klinik für Innere Medizin III, Universitätsklinikum Des Saarlandes, Saarland University, Homburg/Saar, Germany.
Roland E SchmiederDepartment of Nephrology and Hypertension, Universitätsklinikum Erlangen, Erlangen, Germany.
Konstantinos TsioufisDepartment of Cardiology, National and Kapodistrian University of Athens, Hippocratio Hospital, Athens, Greece.
Sidney A CohenDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Martin FahyCoronary and Structural Heart, Medtronic PLC, Santa Rosa, CA, USA.
David E KandzariDepartment of Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCatheter-based renal denervation (RDN) reduces blood pressure (BP) throughout the 24-h period, as reported in several randomized sham-controlled trials. Reduction of BP in the early morning hours is especially important due to increased cardiovascular risks during that time.

objectiveIn this report, we examine the impact of RDN on systolic BP (SBP) and diastolic BP (DBP) during the critical morning surge period in a post-hoc analysis of patients in the SPYRAL HTN-ON MED trial. METHODS AND

resultsAmbulatory BP measurements were collected at baseline and 6 months for treatment and control patient groups over 24-h periods. Average morning BP surge is the difference between average morning BP and average nighttime BP, and the morning surge slope reflects the rate of change of BP from nighttime to morning. Mean morning DBP surge slopes were significantly lower for RDN vs. control groups at 6 months (1.1 vs. 3.6 mmHg/h; p = 0.029). In the RDN group, morning DBP surge slopes were significantly lower at 6 months compared to baseline (1.1 vs. 4.1 mmHg/h; p = 0.006). Similar patterns were observed for mean morning SBP surge slope but did not reach statistical significance.

conclusionsThis decrease in the morning DBP surge slope, an index of the sympathetically-mediated morning BP surge, thus indicates a drop in late morning BP relative to early morning/nocturnal BP in the RDN group. Thus, RDN appears effective in attenuating the slope of morning surge in DBP that might indicate possible benefits in a high-risk hypertensive population. CLINICAL

trial registrationhttps://www.clinicaltrials.gov (NCT02439775), registered May 12, 2015.

Indexed as

AdultBlood PressureBlood Pressure Monitoring, AmbulatoryFemaleHeart Disease Risk FactorsHumansHypertensionMaleMiddle AgedRenal ArterySympathectomyTime FactorsTreatment OutcomeBlood pressureHypertensionMorning surgeRenal denervation

Identifiers

PMID32740754

What OpenQuestion holds

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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 OpenQuestion graph.