Quantifying New Heart Muscle Cells

Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. The investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration.

The study has now been registered on ClinicalTrials.gov, despite its initiation on July 23, 2015, as registration was not mandated at the original study site, the University of Pittsburgh Medical Center. However, following the transfer of the study to Weill Cornell Medicine, adherence to institutional requirements necessitated its registration on ClinicalTrials.gov.

Recruiting

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Key information

Conditions

Tetralogy of Fallot With Pulmonary Stenosis Cardiovascular Diseases Heart Diseases Heart Failure

Age range

30 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University (Morgan Stanley Children's Hospital), New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N15-thymidine

Other

50mg/kg (oral administration)

Primary outcomes

Percentage of labeled cardiomyocytes for each patient

Time frame: 6 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rashida Blackwood, BS, MPH

CONTACT

[email protected]

646-962-9036

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

California Institute of Technology
National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Pilot Study for Quantifying New Heart Muscle Cells

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 19, 2024
Registry last updated: Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed