title: 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).
abstract: OBJECTIVE
  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).
  
  
  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. There were 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.
  
  
  CONCLUSIONS
  Intracoronary injection of autologous BMNC does not improve left ventricular function in patients with NIDCM.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00333827.
authors.affiliation: Instituto Nacional de Cardiologia, Rua das Laranjeiras, 374/5° andar (Pesquisa Clínica), Rio de Janeiro, RJ CEP 22240-006, Brazil.
authors.forename: Helena
authors.initials: H
authors.lastname: Martino
authors.affiliation: Santa Casa de Misericórdia do Paraná, Curitiba, Brazil.
authors.forename: Paulo
authors.initials: P
authors.lastname: Brofman
authors.affiliation: Instituto de Moléstias Cardiovasculares, São José do Rio Preto, Brazil.
authors.forename: Oswaldo
authors.initials: O
authors.lastname: Greco
authors.affiliation: Universidade Federal do Paraná, Curitiba, Brazil.
authors.forename: Ronaldo
authors.initials: R
authors.lastname: Bueno
authors.affiliation: Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.
authors.forename: Luiz
authors.initials: L
authors.lastname: Bodanese
authors.affiliation: Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
authors.forename: Nadine
authors.initials: N
authors.lastname: Clausell
authors.affiliation: Universidade Federal do Amazonas, Manaus, Brazil.
authors.forename: Jaime Arnez
authors.initials: JA
authors.lastname: Maldonado
authors.affiliation: Universidade Federal do Espírito Santo, Vitória, Brazil.
authors.forename: José
authors.initials: J
authors.lastname: Mill
authors.affiliation: Instituto Domingo Braile, São José do Rio Preto, Brazil.
authors.forename: Domingo
authors.initials: D
authors.lastname: Braile
authors.affiliation: Hospital Agamenon Magalhães, Recife, Brazil.
authors.forename: João
authors.initials: J
authors.lastname: Moraes
authors.affiliation: Hospital Pró-Cardíaco, Rio de Janeiro, Brazil.
authors.forename: Suzana
authors.initials: S
authors.lastname: Silva
authors.affiliation: Instituto Nacional de Cardiologia, Rua das Laranjeiras, 374/5° andar (Pesquisa Clínica), Rio de Janeiro, RJ CEP 22240-006, Brazil.
authors.forename: Augusto
authors.initials: A
authors.lastname: Bozza
authors.affiliation: Instituto Nacional de Cardiologia, Rua das Laranjeiras, 374/5° andar (Pesquisa Clínica), Rio de Janeiro, RJ CEP 22240-006, Brazil.
authors.forename: Braulio
authors.initials: B
authors.lastname: Santos
authors.affiliation: Instituto Nacional de Cardiologia, Rua das Laranjeiras, 374/5° andar (Pesquisa Clínica), Rio de Janeiro, RJ CEP 22240-006, Brazil acarlos@biof.ufrj.br.
authors.forename: Antonio
authors.initials: A
authors.lastname: Campos de Carvalho
mesh_terms: D016026:Bone Marrow Transplantation / Q000379:methods*; D002311:Cardiomyopathy, Dilated / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D017079:Exercise Tolerance / Q000502:physiology; D005260:Female; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D010101:Oxygen Consumption; D013318:Stroke Volume / Q000502:physiology; D014182:Transplantation, Autologous / Q000379:methods; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000503:physiopathology / Q000628:therapy
keywords: Cardiomyopathy; Heart failure; Stem cells; Tissue therapy