Evidence map›Paper›PMID 38984947›Full record

ArticleESC heart failure2024

Mechanical dyssynchrony as a selection criterion for cardiac resynchronization therapy: Design of the AMEND-CRT trial.

Alexis Puvrez, Jürgen Duchenne, Erwan Donal, John Gorcsan, Hitesh C Patel, Thomas H Marwick, Otto A Smiseth, Peter Søgaard, Ivan Stankovic, Pedro G Diogo and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in ESC heart failure, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

12 authors.

Alexis PuvrezDepartment of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-9454-7706
Jürgen DuchenneDepartment of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.
Erwan DonalLTSI, Inserm 1099, LTSI, University of Rennes, Rennes, France.
John GorcsanHeart and Vascular Institute, Penn State University College of Medicine, Hershey, Pennsylvania, USA.
Hitesh C PatelDepartment of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.
Thomas H MarwickBaker Heart and Diabetes Institute, Melbourne, Australia.
Otto A SmisethInstitute for Surgical Research, Oslo University Hospital and University of Oslo, Oslo, Norway.
Peter SøgaardDepartment of Cardiology, Aalborg University Hospital and University of Aalborg, Aalborg, Denmark.
Ivan StankovicFaculty of Medicine, University of Belgrade, Belgrade, Serbia.
Pedro G DiogoDepartment of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.
Gábor VörösDepartment of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.
Jens-Uwe VoigtDepartment of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-0575-1888

Funding

Medical Research Future Fund (MRFF) International Clinical Trial Collaborations Program-20.1, Australia MRF2006393Research Foundation - Flanders (FWO), Belgium T002919N
6 · The paper itself

Abstract

aimsOne third of patients do not improve after cardiac resynchronization therapy (CRT). Septal flash (SF) and apical rocking (ApRock) are deformation patterns observed on echocardiography in most patients eligible for CRT. These markers of mechanical dyssynchrony have been associated to improved outcome after CRT in observational studies and may be useful to better select patients. The aim of this trial is to investigate whether the current guideline criteria for selecting patients for CRT should be modified and include SF and ApRock to improve therapy success rate, reduce excessive costs and prevent exposure to device-related complications in patients who would not benefit from CRT.

methodsThe AMEND-CRT trial is a multicentre, randomized, parallel-group, double-blind, sham-controlled trial with a non-inferiority design. The trial will include 578 patients scheduled for CRT according to the 2021 ESC guidelines who satisfy all inclusion criteria. The randomization is performed 1:1 to an active control arm ('guideline arm') or an experimental arm ('echo arm'). All participants receive a device, but in the echo arm, CRT is activated only when SF or ApRock or both are present. The outcome of both arms will be compared after 1 year. The primary outcome measures are the average change in left ventricular end-systolic volume and patient outcome assessed using a modified Packer Clinical Composite Score.

conclusionsThe findings of this trial will redefine the role of echocardiography in CRT and potentially determine which patients with heart failure and a prolonged QRS duration should receive CRT, especially in patients who currently have a class IIa or class IIb recommendation.

Indexed as

Cardiac Resynchronization TherapyHeart FailurePatient SelectionDouble-Blind MethodEchocardiographyEquivalence Trials as TopicFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicStroke VolumeTreatment OutcomeVentricular Function, LeftApical rockingCardiac resynchronization therapyEchocardiographyGuidelinesMethodsSeptal flash

Identifiers

PMID38984947
PMCPMC11631248

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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.