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Quantifying New Heart Muscle Cells

NCT06587165 · Weill Medical College of Cornell University
In plain English

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Official title
A Pilot Study for Quantifying New Heart Muscle Cells
About this study
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.
Eligibility 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.
Study design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: child
Timeline
Starts: 2026-05-15
Estimated completion: 2027-03-01
Last updated: 2026-06-15
Interventions
Other: N15-thymidine
Primary outcomes
  • Percentage of labeled cardiomyocytes for each patient (6 months)
Sponsor
Weill Medical College of Cornell University · other
With: National Heart, Lung, and Blood Institute (NHLBI), California Institute of Technology
Contacts & investigators
ContactRashida Blackwood, BS, MPH · contact · rab4029@med.cornell.edu · 646-962-9036
InvestigatorBernhard Kuhn, MD · principal_investigator, Weill Medical College of Cornell University
All locations (4)
Columbia University (Morgan Stanley Children's Hospital)Not Yet Recruiting
New York, New York, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
Children's Hospital of PhiladelphiaNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Upmc Children'S Hospital of PittsburghNot Yet Recruiting
Pittsburgh, Pennsylvania, United States
Quantifying New Heart Muscle Cells · TrialPath