Evidence map›Paper›PMID 34898655›Full record

Trial reportPloS one2021

Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial.

Maria F Paton, John Gierula, Judith E Lowry, David A Cairns, Kieran Bose Rosling, Charlotte A Cole, Melanie McGinlay, Sam Straw, Rowena Byrom, Richard M Cubbon and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03627585 (Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 44% 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.

NCT03627585 nacompletednot on this map

Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling

TypeinterventionalSponsorUniversity of LeedsRan2017 to 2019Enrolled91ConditionsLeft Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, PacemakerArmsPersonalised programming
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. Is conduction system pacing a panacea for pacemaker therapy?Expert review of medical devices · 2024
    Review
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

12 authors at 2 institutions in 1 country.

Maria F PatonLeeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.ORCID 0000-0001-8517-4621
John GierulaLeeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.
Judith E LowryLeeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.
David A CairnsLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.
Kieran Bose RoslingLeeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.
Charlotte A ColeLeeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
Melanie McGinlayLeeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
Sam StrawLeeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.
Rowena ByromLeeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
Richard M CubbonLeeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.
Mark T KearneyLeeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.
Klaus K WitteLeeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.
University of Leeds · GBLeeds Teaching Hospitals NHS Trust · GB

Funding

British Heart Foundation CH/13/1/30086British Heart Foundation FS/12/80/29821British Heart Foundation FS/17/78/33180British Heart Foundation PG/18/82/34120British Heart Foundation RG/09/010/28087Department of Health ICA-CDRF-2016-02-055
6 · The paper itself

Abstract

backgroundPacemakers are widely utilised to treat bradycardia, but right ventricular (RV) pacing is associated with heightened risk of left ventricular (LV) systolic dysfunction and heart failure. We aimed to compare personalised pacemaker reprogramming to avoid RV pacing with usual care on echocardiographic and patient-orientated outcomes.

methodsA prospective phase II randomised, double-blind, parallel-group trial in 100 patients with a pacemaker implanted for indications other than third degree heart block for ≥2 years. Personalised pacemaker reprogramming was guided by a published protocol. Primary outcome was change in LV ejection fraction on echocardiography after 6 months. Secondary outcomes included LV remodeling, quality of life, and battery longevity.

resultsClinical and pacemaker variables were similar between groups. The mean age (SD) of participants was 76 (+/-9) years and 71% were male. Nine patients withdrew due to concurrent illness, leaving 91 patients in the intention-to-treat analysis. At 6 months, personalised programming compared to usual care, reduced RV pacing (-6.5±1.8% versus -0.21±1.7%; p<0.01), improved LV function (LV ejection fraction +3.09% [95% confidence interval (CI) 0.48 to 5.70%; p = 0.02]) and LV dimensions (LV end systolic volume indexed to body surface area -2.99mL/m2 [95% CI -5.69 to -0.29; p = 0.03]). Intervention also preserved battery longevity by approximately 5 months (+0.38 years [95% CI 0.14 to 0.62; p<0.01)) with no evidence of an effect on quality of life (+0.19, [95% CI -0.25 to 0.62; p = 0.402]).

conclusionsPersonalised programming in patients with pacemakers for bradycardia can improve LV function and size, extend battery longevity, and is safe and acceptable to patients.

trial registrationClinicalTrials.gov identifier: NCT03627585.

Indexed as

Ventricular RemodelingAgedAged, 80 and overBradycardiaDouble-Blind MethodEchocardiographyFemaleHeart VentriclesHumansMaleNatriuretic Peptide, BrainOutcome Assessment, Health CarePacemaker, ArtificialPatient-Specific ModelingPeptide FragmentsQuality of LifeNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)

Identifiers

PMID34898655
PMCPMC8668131
OpenAlexW4200322358

What OpenQuestion holds

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LicenceCC BY
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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.