Evidence map›Paper›PMID 29275370›Full record

Trial reportJournal of the American Heart Association2017

Pacemaker-Mediated Programmable Hypertension Control Therapy.

Petr Neuzil, Béla Merkely, Andrejs Erglis, Germanas Marinskis, Joris R de Groot, Herwig Schmidinger, Manuel Rodriguez Venegas, Michiel Voskuil, Thomas Sturmberger, Jan Petru and 12 more

4 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–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.

NCT02282033 nacompletednot on this map

Clinical Evaluation of Safety and Performance of the BackBeat Moderato System

TypeinterventionalSponsorBackBeat Medical IncRan2013 to 2017Enrolled57ConditionsHypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular BlockArmsThe Moderato System
NCT04463121 nacompletednot on this mapstarted 2020, after this paper: background citation

Pressure-Volume (PV) Measurements for Evaluating the Changes in the Ventricular Preload and Autonomic Nervous System Using BackBeat Medical Cardiac Neuromodulation Therapy (CNT) Signals in an Acute Study

TypeinterventionalSponsorBackBeat Medical IncRan2020 to 2023Enrolled22ConditionsBradycardia, Hypertension, SystolicArmsModerato IPG's CNT pacing signals, CD Leycom Pressure/Volume Combination Catheters
NCT05345925 nacompletednot on this mapstarted 2023, after this paper: background citation

Pressure-Volume (PV) Measurements for Evaluating Cardiac Parameters Using BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals in Different Physiological Pacing Sites: An Acute Study

TypeinterventionalSponsorBackBeat Medical IncRan2023 to 2023Enrolled5ConditionsBradycardia, A-V BlockArmsModerato
NCT06059638 narecruitingnot on this mapstarted 2023, after this paper: background citation

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

TypeinterventionalSponsorOrchestra BioMed, IncRan2023 to 2029Enrolled316ConditionsHypertension, Hypertension, Systolic, Hypertension, EssentialArmsMedtronic Astra/Azure DR MRI IPG with AVIM therapy Activated, Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Device's design and clinical perspectives for resistant hypertension therapy.International journal of cardiology. Cardiovascular risk and prevention · 2024
    Review
  9. Device-Based Therapy for Resistant Hypertension: An Up-to-Date Review.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2022
    Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Device-based therapies for arterial hypertension.Nature reviews. Cardiology · 2020
    Review
  15. Cardiac arrhythmias in arterial hypertension.Journal of clinical hypertension (Greenwich, Conn.) · 2020
    Review
  16. Article
  17. Implant-Mediated Therapy of Arterial Hypertension.Current hypertension reports · 2020
    Review
  18. Article
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Petr NeuzilNa Homolce Hospital, Prague, Czech Republic.
Béla MerkelyHeart and Vascular Center, Semmelweis University Budapest, Budapest, Hungary.
Andrejs ErglisLatvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
Germanas MarinskisVilnius University Hospital Santariskiu Klinikos, Vilnius, Lithuania.
Joris R de GrootDepartment of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
Herwig SchmidingerAbteilung für Kardiologie, AKH - Universitätsklinik für Innere Medizin II, Vienna, Austria.
Manuel Rodriguez VenegasHospital Dr. Sótero del Río, Puente Alto, Santiago, Chile.
Michiel VoskuilDepartment of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
Thomas SturmbergerInterne 2 - Kardiologie, Angiologie & Interne Intensivmedizin, Krankenhaus der Elisabethinen Linz GmbH, Linz, Austria.
Jan PetruNa Homolce Hospital, Prague, Czech Republic.
Niels JongejanDepartment of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
Josef AichingerInterne 2 - Kardiologie, Angiologie & Interne Intensivmedizin, Krankenhaus der Elisabethinen Linz GmbH, Linz, Austria.
Ginta KamzolaLatvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
Audrius AidietisVilnius University Hospital Santariskiu Klinikos, Vilnius, Lithuania.
Laszlo GellérHeart and Vascular Center, Semmelweis University Budapest, Budapest, Hungary.
Tomas MrazNa Homolce Hospital, Prague, Czech Republic.
Istvan OsztheimerHeart and Vascular Center, Semmelweis University Budapest, Budapest, Hungary.
Yuval MikaBackbeat Medical, New Hope, PA.
Steven EvansBackbeat Medical, New Hope, PA.
Daniel BurkhoffCardiovascular Research Foundation, New York City, NY dburkhoff@crf.org.
Karl-Heinz KuckAsklepios Klinik St. Georg, Hamburg, Germany.
BackBeat Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients requiring a pacemaker have persistent hypertension with systolic blood pressures above recommended levels. We evaluated a pacemaker-based Programmable Hypertension Control (PHC) therapy that uses a sequence of variably timed shorter and longer atrioventricular intervals. METHODS AND

resultsPatients indicated for dual-chamber pacing with office systolic blood pressure (oSBP) >150 mm Hg despite stable medical therapy were implanted with a Moderato™ pulse generator that delivers PHC therapy. Patients were followed for 1 month (Run-In period) with conventional pacing; those with persistent oSBP >140 mm Hg were included in the study and had PHC therapy activated. The co-primary efficacy end points were changes in 24-hour ambulatory systolic blood pressure and oSBP between baseline and 3 months. Safety was assessed by tracking adverse events. Thirty-five patients met the initial inclusion criteria and underwent Moderato implantation. At 1 month, oSBP was <140 mm Hg in 7 patients who were excluded. PHC was activated in the remaining 27 patients with baseline office blood pressure 166±11/80±10 mm Hg despite an average of 3.2 antihypertensive medications. During the Run-In period, oSBP and 24-hour ambulatory systolic blood pressure decreased by 8±13 and 5±12 mm Hg (

conclusionsIn pacemaker patients with persistent hypertension despite medical therapy, oSBP and 24-hour ambulatory systolic blood pressure are decreased by PHC therapy. Initial indications are that this therapy is a safe and promising therapy for such patients. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02282033.

Indexed as

Pacemaker, ArtificialAgedBlood PressureBlood Pressure Monitoring, AmbulatoryFemaleFollow-Up StudiesHeart RateHumansHypertensionMaleProspective StudiesTreatment OutcomeAV DelayHypertensionIsolated Systolic HypertensionPacing

Identifiers

PMID29275370
PMCPMC5779015

What OpenQuestion 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 OpenQuestion graph.