Quantifying New Heart Muscle Cells
Part of paid clinical trials in New York, New York.
- Sponsor
- Weill Medical College of Cornell University
- Study ID
- NCT06587165
- Status
- Recruiting
Conditions
- Heart Failure
- Tetralogy of Fallot With Pulmonary Stenosis
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Days - 1 Year
- Healthy Volunteers
- Not accepted
Interventions
- N15-thymidine — OTHER50mg/kg (oral administration)
Study Details
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.
Key Dates
- First listed
- Sep 19, 2024
- Start date
- May 15, 2026
- Status verified
- Jun 2026
- Primary completion
- Mar 1, 2027
- Completion
- Mar 1, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: N15-thymidineStudy participants will receive thymidine preparations for pre-defined blocks of time prior to the scheduled routine resection of myocardium.
Primary Outcome Measure
Percentage of labeled cardiomyocytes for each patient [ Time Frame: 6 months ]
Central Contacts
- Rashida Blackwood, BS, MPH646-962-9036
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University (Morgan Stanley Children's Hospital) | New York | New York | 10032 | Maureen McKiernan, MD Katrina Golub, MPH Maureen McKiernan, MD (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medicine | New York | New York | 10065 | Bernhard Kuhn, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Laura Mercer-Rosa, MD Anh Duc Mai, MS Laura Mercer-Rosa, MD (PRINCIPAL_INVESTIGATOR) |
| Upmc Children'S Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | Shannon Janzef, MSN, RN, CBC Mousumi Moulik (PRINCIPAL_INVESTIGATOR) |
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