Clinical trial Recruiting at 1 site Observational Ages Any age to 20

Characterizing heart tissue development in infants with congenital heart disease

Official title: Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development

Run by Emory University · NCT00243776 · Data updated 2026-11-12

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 typeObservational
AgesAny age to 20 Years
SexAll
Enrollment600 (estimated)
SponsorEmory University
Academic / other
Locations1 site (Atlanta, Georgia)
StatusRecruiting
StartedApril 2005
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedMay 6, 2026
Trial IDNCT00243776 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants undergoing cardiopulmonary bypass surgery for congenital heart defects.

Probably not a fit

Patients with a history of prior cardiac surgery or atrial arrhythmias may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.