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Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Dec 31, 2025 to Dec 2027v22
  2. Minor 2 versions Re-verified since Jun 4, 2024, no change to tracked fieldsv20-v21
  3. Notable Primary and study completion dates: Jan 31, 2023 to Dec 31, 2025v19
  4. Minor 2 versions Re-verified since Jun 3, 2021, no change to tracked fieldsv17-v18
  5. Notable Primary and study completion dates: Jan 31, 2020 to Jan 31, 2023v16
Show 14 earlier versionsHide 14 earlier versions
  1. Minor Eligibility criteria expanded, about 24 wordsv15 Show moreShow less
  2. Notable Primary endpoints: 1 to 2 Primary and study completion dates: Aug 31, 2019 to Jan 31, 2020 · Study description expanded, about 78 words · Collaborators expanded, about 7 words · 1 morev14 Show all 5 changesShow less
    • Primary and study completion dates: Aug 31, 2019 to Jan 31, 2020
    • Study description expanded, about 78 words
    • Collaborators expanded, about 7 words
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Primary and study completion dates: Jul 2017 to Aug 31, 2019v13
  4. Notable Primary and study completion dates: Jul 2016 to Jul 2017 Eligibility criteria expanded, about 14 words · Primary endpoint revised · Study description expanded, about 8 wordsv12 Show all 4 changesShow less
    • Eligibility criteria expanded, about 14 words
    • Primary endpoint revised
    • Study description expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  5. Minor 2 versions Re-verified since Jun 24, 2015, no change to tracked fieldsv10-v11
  6. Minor Study Status, Referencesv9
  7. Notable Primary and study completion dates: Jul 2015 to Jul 2016 Site contact updatedv8 Show all 2 changesShow less
    • Site contact updated
  8. Notable Primary and study completion dates: Jul 2011 to Jul 2015v7
  9. Notable Primary and study completion dates: Jul 2010 to Jul 2011v6
  10. Minor Primary completion date: Jul 2010 Completion date: Jul 2009 to Jul 2010v5 Show all 2 changesShow less
    • Completion date: Jul 2009 to Jul 2010
  11. Minor Study description revisedv4 Show moreShow less
  12. Minor Completion date: Jul 2006 to Jul 2009v3
  13. Minor Completion date: Jul 2006 Start date: Apr 2005v2 Show all 2 changesShow less
    • Start date: Apr 2005
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2,136 trials monitored
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The study team will use small pieces of human hearts which are removed as part of a required surgical procedure to study different objectives. One of the objective is how calcium ions pass through the membrane of heart cells in order to tell the heart cell how much force to contract with when the heart beats. Investigators will also study the proteins and RNA of these pieces to determine how the newborn heart cells control their force of contraction differently from adult heart cells. Investigators hypothesize that infant hearts have different regulation of calcium entry than adult hearts. The study team also wants to study combinations of 3D cardiac spheres with multiple environmental cues that can improve functional and metabolic maturation of Human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) and generate a more clinically relevant cell model.
Trial Details
NCT Number NCT00243776
Lead Sponsor Emory University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Congenital Heart Disease, Tetralogy of Fallot
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov