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NCT04713657 · ClinicalTrials.gov registry record · Phase 1
Beta-blocker Administration for Cardiomyocyte Division
A Phase 1 study of Tetralogy of Fallot and Double Outlet Right Ventricle, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 3
- Study locations
NCT04713657: Recruiting Phase 1 study of Tetralogy of Fallot and Double Outlet Right Ventricle, sponsored by Weill Medical College of Cornell University.
NCT04713657 is a Phase 1 study of Tetralogy of Fallot and Double Outlet Right Ventricle that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 40 participants, below the 184-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04713657, a Phase 1 study of Tetralogy of Fallot and Double Outlet Right Ventricle, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 3
- Study locations
Study Summary
Heart failure is a common long-term complication in patients with congenital heart disease (CHD). Medical treatments to promote regeneration of new healthy heart muscle cells have the potential to provide new heart failure treatments for these patients. The development of such therapies is limited by the poor understanding of the ways in which heart muscles grow after birth. Investigators have learned that humans without heart disease generate new heart muscles cells up to the age of 20 years old and that this is decreased in patients with congenital heart disease like Tetralogy of Fallot. Investigators are trying to determine if treatment with a medicine called Propranolol can increase heart muscle cell proliferation and, with that, normalize heart growth. Investigators will examine discarded heart muscle tissue that is obtained during surgery for the presence of new heart muscle cells. Propranolol is approved by the Food and Drug Administration (FDA) to treat a certain kind of benign tumor in infants (hemangioma), but it is not currently approved by the FDA to increase heart muscle growth.
Primary Outcome
To quantify cardiomyocyte division, investigators will utilize previously established MIMS (membrane introduction mass spectrometry) approach. Briefly, investigators will administer 5 enteral doses of 15N-thymidine to all patients at 1 month after birth. Cardiomyocytes that have undergone DNA replication after the intake of 15N-thymidine will incorporate the stable isotope into their DNA.
Conditions Studied
Interventions
- OTHER Urine Collection
- PROCEDURE Echocardiogram
- DRUG Propranolol Hydrochloride
- OTHER N-thymidine
- PROCEDURE Cardiac MRI (CMR)
Study Locations (3)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Upmc Children'S Hospital of Pittsburgh - Pittsburgh
New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-12-16 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 1 |
What NCT04713657 shows while recruiting
NCT04713657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 184-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Tetralogy of Fallot appearing as the primary indexed condition, and to 5 interventions - of which Urine Collection is the first listed.
NCT04713657 reports a single indexed study location in Pennsylvania, New York.
Frequently Asked Questions
What is clinical trial NCT04713657 about?
NCT04713657 is a clinical study titled "Beta-blocker Administration for Cardiomyocyte Division". Heart failure is a common long-term complication in patients with congenital heart disease (CHD). Medical treatments to promote regeneration of new healthy heart muscle cells have the potential to provide new heart failure treatments for these patients. The development of such therapies is limited b...
What is the current status of trial NCT04713657?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-12-16. Estimated completion is 2030-12-31.
What conditions does trial NCT04713657 study?
This clinical trial studies the following conditions: Tetralogy of Fallot, Double Outlet Right Ventricle.
What interventions are being tested in trial NCT04713657?
The interventions under investigation include: Urine Collection (OTHER), Echocardiogram (PROCEDURE), Propranolol Hydrochloride (DRUG), N-thymidine (OTHER), Cardiac MRI (CMR) (PROCEDURE).
Who is sponsoring clinical trial NCT04713657?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04713657 being conducted?
This trial has 3 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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