Status:
RECRUITING
Beta-blocker Administration for Cardiomyocyte Division
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Tetralogy of Fallot
Double Outlet Right Ventricle
Eligibility:
All Genders
30-60 years
Phase:
PHASE1
Brief 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 pro...
Eligibility Criteria
Inclusion
- Male and female infants \< 60 days of age with a diagnosis of tetralogy of Fallot (ToF) with pulmonary stenosis (PS) or double outlet right ventricle (DORV), tetralogy type by echocardiogram, who weigh greater than 2 kg at the time of consent and are tolerating enteral feeds.
- DORV variant
Exclusion
- congenital atrio-ventricular block on EKG (PR interval \> 120 ms),
- concomitant medication administration that interacts with propranolol,
- patient family is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason,
- gestation age \< 35 weeks,
- infants of diabetic mothers, asthma or underlying respiratory disease,
- presence of metal implants in infants.
Key Trial Info
Start Date :
December 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04713657
Start Date
December 16 2022
End Date
December 31 2030
Last Update
November 18 2025
Active Locations (3)
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1
Weill Cornell Medicine
New York, New York, United States, 10065
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
Upmc Children'S Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224