Quantifying New Heart Muscle Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: N15-thymidine.
- Who it may be relevant to
- Registry conditions: Tetralogy of Fallot With Pulmonary Stenosis, Heart Failure. Basic parameters: 30 Days — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study for Quantifying New Heart Muscle Cells
Overview
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.
Interventions
- Other N15-thymidine
50mg/kg (oral administration)
Primary outcome measures
- Percentage of labeled cardiomyocytes for each patient [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 4 centers
- Columbia University (Morgan Stanley Children's Hospital) — New York
- Weill Cornell Medicine — New York
- Children's Hospital of Philadelphia — Philadelphia
- Upmc Children'S Hospital of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT06587165 · 26-05030237frmrly24-03027194 · 7R01HL151386-05