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

Jozef Bartunek, Beth Davison, Warren Sherman, Thomas Povsic, Timothy D. Henry, Bernard Gersh, Marco Metra, Gerasimos Filippatos, Roger Hajjar, Atta Behfar, Christian Homsy, Gad Cotter, William Wijns, Michal Tendera, Andre Terzic

Research output: Contribution to journalArticle

44 Scopus citations

Abstract

Aims Cardiopoiesis is a conditioning programme that aims to upgrade the cardioregenerative aptitude of patient-derived stem cells through lineage specification. Cardiopoietic stem cells tested initially for feasibility and safety exhibited signs of clinical benefit in patients with ischaemic heart failure (HF) warranting definitive evaluation. Accordingly, CHART-1 is designed as a large randomized, sham-controlled multicentre study aimed to validate cardiopoietic stem cell therapy. Methods Patients (n = 240) with chronic HF secondary to ischaemic heart disease, reduced LVEF (6 bone marrow-derived and lineage-directed autologous cardiopoietic stem cells administered via a retention-enhanced intramyocardial injection catheter or a sham procedure. The primary efficacy endpoint is a hierarchical composite of mortality, worsening HF, Minnesota Living with Heart Failure Questionnaire score, 6 min walk test, LV end-systolic volume, and LVEF at 9 months. The secondary efficacy endpoint is the 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. Conclusion The CHART-1 clinical trial is powered to examine the therapeutic impact of lineage-directed stem cells as a strategy to achieve cardiac regeneration in HF populations. On completion, CHART-1 will offer a definitive evaluation of the efficacy and safety of cardiopoietic stem cells in the treatment of chronic ischaemic HF. Trial registration: NCT01768702

Original languageEnglish (US)
Pages (from-to)160-168
Number of pages9
JournalEuropean Journal of Heart Failure
Volume18
Issue number2
DOIs
StatePublished - Feb 1 2016

Keywords

  • Cardiopoiesis
  • Heart failure
  • Ischaemic cardiomyopathy
  • Regenerative medicine
  • Stem cell

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Bartunek, J., Davison, B., Sherman, W., Povsic, T., Henry, T. D., Gersh, B., Metra, M., Filippatos, G., Hajjar, R., Behfar, A., Homsy, C., Cotter, G., Wijns, W., Tendera, M., & Terzic, A. (2016). Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design. European Journal of Heart Failure, 18(2), 160-168. https://doi.org/10.1002/ejhf.434