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Quantifying New Heart Muscle Cells in Infants

This study aims to understand how the heart regenerates itself in very young children with certain heart conditions. We know that the heart's ability to grow new muscle cells decreases after birth, but we don't know exactly when this happens or how heart disease affects it. Researchers will give a small amount of N15-thymidine (an oral medication) to infants aged 30 days to 1 year who are having heart surgery for Tetralogy of Fallot with Pulmonary Stenosis or Heart Failure. The main goal is to measure the percentage of new heart muscle cells in each patient after 6 months. This will help us learn more about heart regeneration in children and potentially lead to new treatments for heart failure.

Study design
This is an interventional study planning to enroll 30 participants. The phase of the study is not specified.
What's involved
Participants will receive N15-thymidine orally before their scheduled heart surgery. The primary measurement will be taken 6 months after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months to measure the percentage of labeled cardiomyocytes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06587165

Quantifying New Heart Muscle Cells

Recruiting
NAAges 30–1InterventionalBasic science
Weill Medical College of Cornell University
~30 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:N15-thymidine

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of labeled cardiomyocytes for each patient
Measured over 6 months

Conditions

Tetralogy of Fallot With Pulmonary Stenosis
Heart Failure

Explore related trials

Heart FailureTetralogy of Fallot

NCT06587165

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniastudy coordinator listed

    Not yet recruiting

  • Columbia University (Morgan Stanley Children's Hospital)

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

  • Upmc Children'S Hospital of Pittsburgh

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Not yet recruiting

  • Weill Cornell Medicine

    New York, New Yorkstudy coordinator listed

    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

  • Bernhard Kuhn, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Rashida Blackwood, BS, MPH
[email protected]
646-962-9036
Email the study team

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Eligibility criteria

Inclusion

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

Patients with low chance of having resection of myocardium as part of their surgical care.

What this trial measures

  • Percentage of labeled cardiomyocytes for each patient6 months

    The investigators will use, multi-isotope imaging mass spectrometry (MIMS) to quantify the generation of new cardiomyocytes by examining myocardial samples that are routinely resected and discarded during cardiac surgery. Investigators will then calculate the percentage of labeled, i.e. newly generated, cardiomyocytes, for each patient. The data from the analysis of myocardial samples will be the test results. Investigators will first compare these results with technical controls.