Evidence map›Paper›PMID 38281309›Full record

ArticleCardiology and therapy2024

Effect of Macitentan in Pulmonary Arterial Hypertension and the Relationship Between Echocardiography and cMRI Variables: REPAIR Echocardiography Sub-study Results.

Adam Torbicki, Richard Channick, Nazzareno Galiè, David G Kiely, Pamela Moceri, Andrew Peacock, Andrew J Swift, Ahmed Tawakol, Anton Vonk Noordegraaf, Dayana Flores and 2 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cardiology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02310672 (A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 40% 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.

NCT02310672 phase4completednot on this map

A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

TypeinterventionalSponsorActelionRan2015 to 2019Enrolled89ConditionsPulmonary Arterial HypertensionArmsMacitentan
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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 10 institutions in 7 countries.

Adam TorbickiDepartment of Pulmonary Circulation, Thromboembolic Disease and Cardiology, Centre for Postgraduate Medical Education ECZ-Otwock, ERN-LUNG Member, F. Chopin Hospital European Health Centre, ul. Borowa 14/18, 05-400, Otwock, Poland. atorbicki@gmail.com.ORCID http://orcid.org/0000-0003-3475-8832
Richard ChannickDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Nazzareno GalièCardiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna and Dipartimento DIMES, Università di Bologna, Bologna, Italy.
David G KielySheffield Pulmonary Vascular Disease Unit, NIHR Biomedical Research Centre Sheffield and University of Sheffield, Sheffield, UK.
Pamela MoceriCardiology Department, UR2CA, Pasteur University Hospital, Côte-d'Azur University, Nice, France.
Andrew PeacockScottish Pulmonary Vascular Unit, Glasgow, UK.
Andrew J SwiftDepartment of Infection, Immunity & Cardiovascular Disease, National Institute for Health and Care Research Sheffield Biomedical Research Centre, University of Sheffield, Sheffield, UK.
Ahmed TawakolMassachusetts General Hospital and Harvard Medical School, Boston, USA.
Anton Vonk NoordegraafAmsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Dayana FloresActelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, Global Medical Affairs, Allschwil, Switzerland.
Nicolas MartinActelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, Statistical Decision Science, Allschwil, Switzerland.
Stephan RosenkranzDepartment of Cardiology, Heart Center, University Hospital Cologne, and Cologne Cardiovascular Research Center (CCRC), University of Cologne, Cologne, Germany.
Johnson & Johnson (Switzerland) · CHUniversity of Sheffield · GBAmsterdam University Medical Centers · NLAzienda USL di Bologna · ITEuropean Hospital · ITHarvard University · USHôpital Pasteur · FRPulmonary Vascular Research Institute · GBUniversity of California, Los Angeles · USUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this sub-study was to evaluate the relationship between echocardiography (echo) and cardiac magnetic resonance imaging (cMRI) variables and to utilize echo to assess the effect of macitentan on right ventricle (RV) structure and function.

methodsREPAIR (NCT02310672) was a prospective, multicenter, single-arm, open-label, 52-week, phase 4 study in pulmonary arterial hypertension (PAH) patients, which investigated the effect of macitentan 10 mg as monotherapy, or in combination with a phosphodiesterase 5 inhibitor, on RV structure, function, and hemodynamics using cMRI and right heart catheterization. In this sub-study, patients were also assessed by echo at screening and at weeks 26 and/or 52. Post hoc correlation analyses between echo and cMRI variables were performed using Pearson's correlation coefficient, Spearman's correlation coefficient, and Bland-Altman analyses.

resultsThe Echo sub-study included 45 patients. Improvements in echo-assessed RV stroke volume (RVSV), left ventricular SV (LVSV), LV end-diastolic volume (LVEDV), RV fractional area change (RVFAC), tricuspid annular plane systolic excursion (TAPSE), and in 2D global longitudinal RV strain (2D GLRVS) were observed at weeks 26 and 52 compared to baseline. There was a strong correlation between echo (LVSV, 2D GLRVS, and LVEDV) and cMRI variables, with a moderate correlation for RVSV. Bland-Altman analyses showed a good agreement for LVSV measured by echo versus cMRI, whereas an overestimation in echo-assessed RVSV was observed compared to cMRI (bias of - 15 mL). Hemodynamic and functional variables, as well as safety, were comparable between the Echo sub-study and REPAIR.

conclusionsA good relationship between relevant echo and cMRI parameters was shown. Improvements in RV structure and function with macitentan treatment was observed by echo, consistent with results observed by cMRI in the primary analysis of the REPAIR study. Echo is a valuable complementary method to cMRI, with the potential to non-invasively monitor treatment response at follow-up. TRIAL REGISTRATION NUMBER: REPAIR NCT02310672.

Indexed as

AgreementCardiac magnetic resonance imagingCorrelationEchocardiographyMacitentanPulmonary arterial hypertension

Identifiers

PMID38281309
PMCPMC10899124
OpenAlexW4391293819

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.