Multicentre, Randomized, Double-Blind Trial of Intracoronary Autologous Mononuclear Bone Marrow Cell Injection in Non-Ischaemic Dilated Cardiomyopathy (The Dilated Cardiomyopathy Arm of the MiHeart Study)

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dc.contributor.authorMartino, Helena
dc.contributor.authorBrofman, Paulo
dc.contributor.authorGreco, Oswaldo
dc.contributor.authorBueno, Ronaldo
dc.contributor.authorBodanese, Luiz
dc.contributor.authorClausell, Nadine
dc.contributor.authorMaldonado, Jaime Arnez
dc.contributor.authorMill, José
dc.contributor.authorBraile, Domingo
dc.contributor.authorMoraes Jr, João
dc.contributor.authorSilva, Suzana
dc.contributor.authorBozza, Augusto
dc.contributor.authorSantos, Braulio
dc.contributor.authorCarvalho, Antonio Campos de
dc.contributor.authorDilated Cardiomyopathy Arm of the MiHeart Study Investigators
dc.date.accessioned2022-09-06T14:30:54Z
dc.date.available2022-09-06T14:30:54Z
dc.date.issued2015
dc.description.abstractAims: Pre-clinical and few clinical studies suggest that transplantation of autologous bone marrow mononuclear cells (BMNC) improves heart function in dilated cardiomyopathies. Our objective was to determine if intracoronary injection of autologous BMNC improves the left ventricular ejection fraction (LVEF) of patients with non-ischaemic dilated cardiomyopathy (NIDCM). Methods and results: This study was a multicentre, randomized, double-blind, placebo controlled trial with a follow-up of 12 months. Patients with NIDCM and LVEF ,35% were recruited at heart failure ambulatories in specialized hospitals around Brazil. One hundred and sixty subjects were randomized to intracoronary injection of BMNC or placebo (1:1). The primary endpoint was the difference in change of LVEF between BMNC and placebo groups as determined by echocardiography. One hundred and fifteen patients completed the study. Left ventricular ejection fraction decreased from 24.0% (21.6–26.3) to 19.9% (15.4–24.4) in the BMNC group and from 24.3% (22.1–26.5) to 22.1% (17.4–26.8) in the placebo group. Therewere no significant differences in changes between cell and placebo groups for left ventricular systolic and diastolic volumes and ejection fraction. Mortality rate was 20.37% in placebo and 21.31% in BMNC. Conclusion: Intracoronary injection of autologous BMNC does not improve left ventricular function in patients with NIDCM.en
dc.identifier.citationMartino H, Brofman P, Greco O, Bueno R, Bodanese L, Clausell N et al. Multicentre, Randomized, Double-Blind Trial of Intracoronary Autologous Mononuclear Bone Marrow Cell Injection in Non-Ischaemic Dilated Cardiomyopathy (The Dilated Cardiomyopathy Arm of the MiHeart Study). Eur Heart J. 2015 Nov 7;36(42):2898-904. doi: 10.1093/eurheartj/ehv477.
dc.identifier.otherDOI: 10.1093/eurheartj/ehv477
dc.identifier.otherClinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00333827.
dc.identifier.urihttps://dspace.inc.saude.gov.br/handle/123456789/211
dc.language.isoen
dc.publisherEuropean Heart Journal
dc.subjectTerapia Baseada em Transplante de Células e Tecidospt
dc.subjectCélulas-troncopt
dc.subjectInsuficiência cardíacapt
dc.subjectCardiomiopatiaspt
dc.subjectTissue therapyen
dc.subjectStem cellsen
dc.subjectHeart failureen
dc.subjectCardiomyopathyen
dc.subject.meshVentricular Dysfunction, Left / therapyen
dc.subject.meshVentricular Dysfunction, Left / physiopathologyen
dc.subject.meshTreatment Outcomeen
dc.subject.meshTransplantation, Autologous / methodsen
dc.subject.meshStroke Volume / physiologyen
dc.subject.meshOxygen Consumptionen
dc.subject.meshInjections, Intralesionalen
dc.subject.meshMaleen
dc.subject.meshInjections, Intralesionalen
dc.subject.meshHumansen
dc.subject.meshFemaleen
dc.subject.meshExercise Tolerance / physiologyen
dc.subject.meshDouble-Blind Methoden
dc.subject.meshCardiomyopathy, Dilated / therapyen
dc.subject.meshCardiomyopathy, Dilated / physiopathologyen
dc.subject.meshBone Marrow Transplantation / methodsen
dc.titleMulticentre, Randomized, Double-Blind Trial of Intracoronary Autologous Mononuclear Bone Marrow Cell Injection in Non-Ischaemic Dilated Cardiomyopathy (The Dilated Cardiomyopathy Arm of the MiHeart Study)en
dc.typeArticle
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