Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 2027v22
  2. 2 versions Re-verified since Jun 4, 2024, no change to tracked fieldsv20-v21
  3. Primary and study completion dates: Jan 31, 2023 to Dec 31, 2025v19
  4. 2 versions Re-verified since Jun 3, 2021, no change to tracked fieldsv17-v18
  5. Primary and study completion dates: Jan 31, 2020 to Jan 31, 2023v16
Show 14 earlier versionsHide 14 earlier versions
  1. Eligibility criteria expanded, about 24 wordsv15
  2. Primary endpoints: 1 to 2v14 Show 4 more 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
  3. Primary and study completion dates: Jul 2017 to Aug 31, 2019v13
  4. Primary and study completion dates: Jul 2016 to Jul 2017
    • Eligibility criteria expanded, about 14 words
    • Primary endpoint revised
    • Study description expanded, about 8 words
    v12
  5. 2 versions Re-verified since Jun 24, 2015, no change to tracked fieldsv10-v11
  6. Study Status, Referencesv9
  7. Primary and study completion dates: Jul 2015 to Jul 2016
    • Site contact updated
    v8
  8. Primary and study completion dates: Jul 2011 to Jul 2015v7
  9. Primary and study completion dates: Jul 2010 to Jul 2011v6
  10. Primary completion date: Jul 2010
    • Study completion date: Jul 2009 to Jul 2010
    v5
  11. Study description revisedv4
  12. Study completion date: Jul 2006 to Jul 2009v3
  13. Study completion date: Jul 2006
    • Start date: Apr 2005
    v2
  1. Study First Submitted
  • 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.
Emory University
378 trials monitored
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Heart Disease
8,844 trials monitored
See 432 trials at risk
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
(from sponsor)		 Congenital Heart Disease, Tetralogy of Fallot
Related terms Heart Defects, Congenital, Tetralogy of Fallot
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov