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Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development
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.
Conditions:
🦠 Congenital Heart Disease 🦠 Tetralogy of Fallot
🗓️ Study Start (Actual) April 2005
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 600
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients undergoing cardiopulmonary bypass surgery
    • * Patients undergoing surgery for repair of congenital heart disease such as ventricular septal defect or defective mitral or aortic valves.

    Exclusion Criteria:

    • * Prior cardiac surgery
    • * History of atrial fibrillation or other atrial arrhythmias prior to operation
    • * History of heart failure
Ages Eligible for Study: N/A to 20 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 October 2005
  • First Submitted that Met QC Criteria 24 October 2005
  • First Posted 25 October 2005

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 June 2024
  • Last Update Posted 5 June 2024
  • Last Verified June 2024
I'm interested ...!!