Evidence map›Paper›PMID 38348238›Full record

ArticleERJ open research2024

Comparison of cardiac magnetic resonance imaging, functional and haemodynamic variables in pulmonary arterial hypertension: insights from REPAIR.

David G Kiely, Richard Channick, Dayana Flores, Nazzareno Galiè, Gwen MacDonald, J Tim Marcus, Lada Mitchell, Andrew Peacock, Stephan Rosenkranz, Ahmed Tawakol and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in ERJ open research, 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 41% 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. 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

13 authors at 9 institutions in 6 countries.

David G KielySheffield Pulmonary Vascular Disease Unit and NIHR Biomedical Research Centre, Royal Hallamshire Hospital and University of Sheffield, Sheffield, UK.ORCID https://orcid.org/0000-0003-0184-6502
Richard ChannickDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Dayana FloresGlobal Medical Affairs, Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, Allschwil, Switzerland.
Nazzareno GalièCardiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Gwen MacDonaldGlobal Medical Affairs, Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, Allschwil, Switzerland.
J Tim MarcusAmsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Lada MitchellStatistical Decision Science, Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, Allschwil, Switzerland.
Andrew PeacockStatistical Decision Science, Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, Allschwil, Switzerland.
Stephan RosenkranzScottish Pulmonary Vascular Unit, Glasgow, UK.
Ahmed TawakolDepartment of Cardiology, Heart Center, University Hospital Cologne and Cologne Cardiovascular Research Center, University of Cologne, Cologne, Germany.ORCID https://orcid.org/0000-0002-9211-5483
Adam TorbickiCardiology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.ORCID https://orcid.org/0000-0003-3475-8832
Anton Vonk NoordegraafAmsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.ORCID https://orcid.org/0000-0002-4057-758X
Andrew J SwiftDepartment of Clinical Medicine, University of Sheffield, Sheffield, UK.
Johnson & Johnson (Switzerland) · CHAmsterdam University Medical Centers · NLHarvard University · USAzienda USL di Bologna · ITPulmonary Vascular Research Institute · GBRoyal Hallamshire Hospital · GBUniversity of California, Los Angeles · USUniversity of Cologne · DEUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Measures that can detect large treatment effects are important for monitoring therapeutic effectiveness. The 2022 European Society of Cardiology/European Respiratory Society guidelines highlight the importance of imaging in monitoring disease status and treatment response in pulmonary arterial hypertension (PAH). Are the standardised treatment effect sizes (STES) of cardiac magnetic resonance imaging (cMRI) comparable with functional and haemodynamic variables? Methods: REPAIR (ClinicalTrials.gov: NCT02310672) was a prospective, multicentre, single-arm, open-label, 52-week phase 4 study evaluating the effect of macitentan 10 mg, with or without a phosphodiesterase 5 inhibitor (PDE5i), on right ventricular (RV) remodelling, cardiac function and cardiopulmonary haemodynamics. Both cMRI and functional assessments were performed at screening and at weeks 26 and 52; haemodynamic measurements were conducted at screening and week 26. In this Results: At week 26, large STES (Cohen's d) were observed for 10 of the 20 cMRI variables assessed, including the prognostic measures of RV and left ventricular stroke volume and RV ejection fraction and the haemodynamic trial end-point, pulmonary vascular resistance; medium STES were observed for 6-min walk distance (6MWD). The STES were consistent in treatment-naïve patients and those escalating therapy and maintained at week 52. Similar results were obtained using the non-parametric Cliff's delta method. Conclusions: The treatment effect of macitentan, alone or in combination with a PDE5i, was comparable for several cMRI and haemodynamic variables with prognostic value in PAH, and greater than that of 6MWD in patients with PAH, highlighting the emerging relevance of cMRI in PAH.

Identifiers

PMID38348238
PMCPMC10860210
OpenAlexW4390941154

What OpenQuestion holds

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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.