Measuring new heart muscle growth in infants with congenital heart defects
A Pilot Study for Quantifying New Heart Muscle Cells
This protocol will use labeled thymidine during planned heart surgery to see if infants (30 days–1 year) still make new heart muscle cells and how much.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 30 Days to 1 Year |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06587165 on ClinicalTrials.gov |
What this trial studies
The protocol uses stable isotope–labeled N15-thymidine to mark newly synthesized DNA in cardiomyocytes removed during planned surgical resections in infants. Infants aged 30 days to 1 year undergoing elective cardiac surgery for conditions such as Tetralogy of Fallot with pulmonary stenosis are enrolled when the operation is likely to include myocardial resection. Harvested myocardial tissue will be analyzed to quantify rates of cardiomyocyte generation and to map how regenerative capacity changes in early life and with congenital heart disease. The project began at the University of Pittsburgh Medical Center and was later transferred to Weill Cornell Medicine, where the study was registered on ClinicalTrials.gov.
Who should consider this trial
Good fit: Infants aged 30 days to 1 year with Tetralogy of Fallot with pulmonary stenosis or other congenital heart defects scheduled for elective cardiac surgery that is likely to include myocardial resection are ideal candidates.
Not a fit: Patients who are not having surgery that removes myocardial tissue, as well as older children and adults, are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could show when and how infant hearts make new muscle and guide treatments to boost heart repair after injury.
How similar studies have performed: Animal studies and limited human observations suggest neonatal hearts can regenerate, but direct labeling of new human cardiomyocytes with N15-thymidine is novel and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients at 30 days of age to 1 year of age undergoing scheduled elective cardiac surgery will be eligible for study inclusion. * The investigators will recruit patients at 30 days of age to 1 year of age with those types of heart disease whose surgical approach has a high probability of myocardial resection. * Diagnosis of ToF/PS or other types of heart disease that have a high likelihood of requiring surgery that involves routine resection of myocardium that becomes available for research Exclusion Criteria: * Patients with low chance of having resection of myocardium as part of their surgical care.
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Bernhard Kuhn, MD — Weill Medical College of Cornell University
- Study coordinator: Rashida Blackwood, BS, MPH
- Email: rab4029@med.cornell.edu
- Phone: 646-962-9036
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.