-
Views
-
Cite
Cite
Helena Martino, Paulo Brofman, Oswaldo Greco, Ronaldo Bueno, Luiz Bodanese, Nadine Clausell, Jaime Arnez Maldonado, José Mill, Domingo Braile, João Moraes, Suzana Silva, Augusto Bozza, Braulio Santos, Antonio Campos de Carvalho, for the Dilated Cardiomyopathy Arm of the MiHeart Study Investigators, 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), European Heart Journal, Volume 36, Issue 42, 7 November 2015, Pages 2898–2904, https://doi.org/10.1093/eurheartj/ehv477
- Share Icon Share
Abstract
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).
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.
Intracoronary injection of autologous BMNC does not improve left ventricular function in patients with NIDCM.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00333827.
- ventricular function, left
- left ventricular ejection fraction
- cardiomyopathy, dilated
- echocardiography
- heart failure
- left ventricle
- bone marrow cells
- brazil
- diastole
- follow-up
- systole
- arm
- bone marrow
- mortality
- transplantation
- cardiac function
- ejection fraction
- dilated cardiomyopathy, non-ischemic
- mononuclear cells
- intracoronary route
- clinical trial registration