Intracoronary Autologous Mononuclear Bone Marrow Cell Injection in NonIschemic Dilated Cardiomyopathy - MiHeart Study

Oct 05, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Brazilian Ministry of Health
Date Published:
09/21/2015
Original Posted Date:
10/05/2015
References

Description:

The goal of the trial was to evaluate treatment with bone marrow derived mononuclear cells compared with placebo among subjects with nonischemic dilated cardiomyopathy.

Contribution to the Literature: The MiHeart study failed to show that bone marrow derived mononuclear cells improve left ventricular ejection fraction.

Study Design

  • Randomized
  • Parallel
  • Blinded

Subjects with nonischemic dilated cardiomyopathy were randomized to intracoronary injection of bone marrow derived mononuclear cells (n = 82) versus placebo (n = 78).

  • Total number of enrollees: 160
  • Duration of follow-up: 12 months
  • Mean patient age: 50 years
  • Percentage female: 31%
  • Mean left ventricular ejection fraction: 25%

Inclusion criteria:

  • 18-75 years of age
  • Heart failure symptoms for at least 1 year due to nonischemic cardiomyopathy
  • Left ventricular ejection fraction <35%

Exclusion criteria:

  • Valvular heart disease
  • Coronary stenosis >50%
  • Systemic hypertension
  • Chagas disease
  • Sustained ventricular tachycardia
  • Alcohol or drug abuse
  • Pregnancy
  • Use of cardiotoxic drugs
  • Serum creatinine >2.0 mg/dl or prior dialysis
  • Implantable pacemaker or cardioverter defibrillator
  • Limited survival (i.e., <2 years)

Principal Findings:

The primary outcome, change in left ventricular ejection fraction from baseline to 12 months, was -2.9% in the bone marrow mononuclear cell group versus -5.4% in the placebo group (p = 0.47 between groups).

Secondary outcomes:

  • Mortality: 20.3% with mononuclear cells vs. 21.3% with placebo
  • Maximal oxygen consumption from baseline to 12 months: -4.0 ml/kg/min with mononuclear cells vs. -8.4 ml/kg/min with placebo (p = 0.20 between groups)

Interpretation:

Among individuals with nonischemic dilated cardiomyopathy, intracoronary injection of bone marrow derived mononuclear cells failed to improve left ventricular ejection fraction. To date, autologous stem cells have not been able to demonstrate a clinically significant improvement in left ventricular function among patients with cardiomyopathy.

References:

Martino H, Brofman P, Greco O, et al., on behalf of 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. Eur Heart J 2015;Sep 21:[Epub ahead of print].

Keywords: Bone Marrow Cells, Bone Marrow, Cardiomyopathies, Cardiomyopathy, Dilated, Heart Failure, Stem Cells, Stroke Volume, Ventricular Function, Left, Cardiotoxicity


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