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Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design

Jozef Bartunek1, Beth Davison2, Warren Sherman3

  • 1Cardiovascular Centre, OLV Hospital, Aalst, Belgium.

European Journal of Heart Failure
|December 15, 2015
PubMed

Insights

This study investigates cardiopoietic stem cell therapy for chronic ischaemic heart failure (HF). The CHART-1 trial aims to definitively evaluate the efficacy and safety of these stem cells for cardiac regeneration in HF patients.

Area of Science:

  • Cardiology
  • Regenerative Medicine
  • Stem Cell Therapy

Background:

  • Cardiopoiesis enhances stem cell cardioregenerative potential through lineage specification.
  • Previous studies showed feasibility and safety of cardiopoietic stem cells, with early signs of clinical benefit in heart failure (HF).
  • The CHART-1 trial (NCT01768702) is a large, randomized, sham-controlled multicenter study to validate this therapy.

Purpose of the Study:

  • To validate the efficacy and safety of cardiopoietic stem cell therapy for patients with chronic ischaemic heart failure.
  • To assess the therapeutic impact of lineage-directed stem cells for cardiac regeneration.
  • To provide definitive evaluation of stem cell therapy in HF populations.

Main Methods:

  • 240 patients with chronic HF, reduced LVEF (<35%), and high risk for HF events were randomized 1:1.
  • Intervention: 600 × 10^6 autologous cardiopoietic stem cells via intramyocardial injection vs. sham procedure.
  • Primary endpoint: Hierarchical composite of mortality, worsening HF, quality of life, functional capacity, and ventricular remodeling at 9 months.

Main Results:

  • Primary efficacy endpoint analysis is pending completion of the trial.
  • Secondary efficacy endpoint: Time to cardiovascular death or worsening HF at 12 months.
  • Safety endpoints include mortality, readmissions, aborted sudden deaths, and serious adverse events at 12 and 24 months.

Conclusions:

  • The CHART-1 trial is powered to definitively evaluate the efficacy and safety of cardiopoietic stem cells for cardiac regeneration in chronic ischaemic HF.
  • Results will determine the therapeutic impact of lineage-directed stem cells in HF populations.
Abstract

Keywords:
CardiopoiesisHeart failureIschaemic cardiomyopathyRegenerative medicineStem cell

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