Characterizing heart tissue development in infants with congenital heart disease
Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development
This study looks at heart tissue from infants with congenital heart disease to see how it works differently than in adults, hoping to find better treatments for these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | N/A to 20 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT00243776 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the molecular and cellular characteristics of cardiac tissue in infants undergoing surgery for congenital heart disease. Researchers will analyze small samples of heart tissue to understand how calcium ions regulate heart cell contraction differently in infants compared to adults. The study will also explore the development of human pluripotent stem cell-derived cardiomyocytes in a 3D environment to enhance their functional and metabolic maturation. By examining these differences, the study seeks to improve therapeutic approaches for congenital heart conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are infants undergoing cardiopulmonary bypass surgery for congenital heart defects.
Not a fit: Patients with a history of prior cardiac surgery or atrial arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more effective treatments for infants with congenital heart disease.
How similar studies have performed: While there have been studies on adult heart cells, this approach focusing on infant heart cells is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Michael E Davis, PhD — Emory University
- Study coordinator: Michael E Davis, PhD
- Email: medavis@emory.edu
- Phone: 404-727-9858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.