Evidence map›Paper›PMID 34387126›Full record

Trial reportJournal of the American Heart Association2021

Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study.

Zbigniew Kalarus, Béla Merkely, Petr Neužil, Marcin Grabowski, Przemysław Mitkowski, Germanas Marinskis, Andrejs Erglis, Jarosław Kaźmierczak, Thomas Sturmberger, Adam Sokal and 10 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

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

16 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Interventional Treatment of Arterial Hypertension in The Modern Era: An Updated Review from the Young Investigator Group of the European Society of Hypertension.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2026
    Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Device's design and clinical perspectives for resistant hypertension therapy.International journal of cardiology. Cardiovascular risk and prevention · 2024
    Review
  13. 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
  14. Review
  15. Article
  16. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 11 institutions in 7 countries.

Zbigniew KalarusDepartment of Cardiology DMS in ZabrzeMedical University of Silesia Katowice Poland.
Béla MerkelyHeart and Vascular Center Semmelweis University Budapest Hungary.
Petr NeužilDepartment of Cardiology Na Homolce Hospital Prague Czech Republic.
Marcin Grabowski1st Chair and Department of Cardiology Medical University of Warsaw Poland.
Przemysław Mitkowski1st Department of Cardiology Karol Marcinkowski University of Medical Sciences Poznań Poland.
Germanas MarinskisDepartment of Cardiovascular Diseases Centre for Cardiology and Angiology Vilnius University Vilnius Lithuania.
Andrejs ErglisPauls Stradins Clinical University Hospital University of Latvia Riga Latvia.
Jarosław KaźmierczakDepartment of Cardiology Pomeranian Medical University Szczecin Poland.
Thomas SturmbergerInterne 2 - Kardiologie, Angiologie & Interne Intensivmedizin Ordensklinikum Linz GmbH Elisabethinen Linz Austria.
Adam SokalDepartment of Cardiology DMS in ZabrzeMedical University of Silesia Katowice Poland.
Slawomir PlutaDepartment of Cardiology DMS in ZabrzeMedical University of Silesia Katowice Poland.
László GellérHeart and Vascular Center Semmelweis University Budapest Hungary.
István OsztheimerHeart and Vascular Center Semmelweis University Budapest Hungary.
Filip MalekDepartment of Cardiology Na Homolce Hospital Prague Czech Republic.
Agnieszka Kolodzińska1st Chair and Department of Cardiology Medical University of Warsaw Poland.
Yuval MikaOrchestra Biomed New York NY.
Steven J EvansOrchestra Biomed New York NY.
Harold M HastingsDivision of Science, Mathematics and Computing Bard College at Simon's Rock Great Barrington MA.
Daniel BurkhoffCardiovascular Research Foundation New York NY.
Karl-Heinz KuckLANS Cardio Hamburg Germany.
Medical University of Silesia · PLSemmelweis University · HUMedical University of Warsaw · PLNa Homolce Hospital · CZBard College at Simon's Rock · USCardiovascular Research Foundation · USKrankenhaus der Elisabethinen · ATPauls Stradiņš Clinical University Hospital · LVPomeranian Medical University · PLPoznan University of Medical Sciences · PLVilnius University · LT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double-blind randomized pilot study. Methods and Results Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual-chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1-month run-in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between-group difference of the change in 24-hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, -15.2 to -8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (-7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (-14.2 to -1.9 mm Hg) (

Indexed as

Blood PressureCardiac Pacing, ArtificialHeart RatePacemaker, ArtificialAgedAged, 80 and overDouble-Blind MethodEuropeFemaleHeartHumansHypertensionMalePilot ProjectsProspective StudiesTime Factorsatrioventricular intervalhypertensionleft ventricular functionpacemaker

Identifiers

PMID34387126
PMCPMC8475046
OpenAlexW3189579272

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.