Quantifying New Heart Muscle Cells
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-1
SponsorWeill Medical College of Cornell University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with low chance of having resection of myocardium as part of their surgical care.
Trial design
Design model
Single group
Treatments tested in this trial
N15-thymidine
Other intervention50mg/kg (oral administration)
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: N15-thymidineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of labeled cardiomyocytes for each patient
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.
Time frame
6 monthsSponsors and contacts
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Weill Medical College of Cornell University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
California Institute of Technology
Collaborator
Source ClinicalTrials.gov