Observational Study of Heart Tissue in Children with Congenital Heart Disease
This observational study is looking at small pieces of heart tissue from children (ages newborn to 20 years old) who are having heart surgery for conditions like congenital heart disease (heart problems present at birth) or tetralogy of Fallot (a specific type of congenital heart defect). The researchers want to understand how heart cells in infants and children work differently from adult heart cells, especially how calcium ions move through the heart cell membrane to control how strongly the heart contracts. They will also study the proteins and RNA in these heart tissue samples. The goal is to learn more about how young hearts develop and function, which could help improve treatments in the future. You might be able to participate if you are undergoing cardiopulmonary bypass surgery or surgery for congenital heart disease, and have not had prior heart surgery or certain heart rhythm problems.
- Study design
- This is an observational study with a planned enrollment of 600 participants. It is not testing a specific intervention or drug.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure calcium current for up to 13 years and changes in heart cell maturation for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development
At a glance
Conditions
NCT00243776
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Emory University School of Medicine
Atlanta, Georgiano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Michael E Davis, PhD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Calcium Current MeasuresDuration of Study (Up to 13 Years)
Calcium currents including transients and modulation of calcium handling by activation of different pathways in isolated cells from waste tissue obtained at the time of surgical repair for Congenital Heart Disease will be measured for the duration of the study.
- Change in structural, functional and metabolic maturation of Human pluripotent stem cell derived Cardiomyocytes (hPSC-CMs)Duration of Study (Up to 3 Years)
Change in structural, functional and metabolic maturation of Human pluripotent stem cell derived Cardiomyocytes (hPSC-CMs) is achieved using combinations of 3D cardiac spheres with multiple environmental cues to improve mitochondrial fatty acid oxidation (FAO or beta-oxidation) pathway will promote functional and metabolic maturation of hPSC-CMs and generate a more clinically relevant model. The outcome will be measured whether the cells achieved maturation (structural, functional and metabolic maturation) or not after using combinations of 3D cardiac spheres with multiple environmental cues.