Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
About this trial
This is an interventional treatment trial for Tetralogy of Fallot focused on measuring Tetralogy of Fallot, Double Outlet Right Ventricle
Eligibility Criteria
Inclusion Criteria:
- Male and female infants < 45 days of age with a diagnosis of tetralogy of Fallot with pulmonary stenosis or double outlet right ventricle, tetralogy type by echocardiogram, who weigh greater than 2 kg at the time of consent and are tolerating enteral feeds.
Exclusion Criteria:
- 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,
- DORV variant
- infants of diabetic mothers, asthma or underlying respiratory disease,
- presence of metal implants in infants.
Sites / Locations
- UPMC Children's Hospital of PittsburghRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Propranolol
Placebo
The target dose of Propranolol hydrochloride for this study target dose for this study will be 4 mg/kg/day divided in 4 doses. The concentration of propranolol solution is 20 mg/5 mL. Additionally, labeled syringes will be provided to families for accurate weight-based dosing. Treatment with propranolol will begin at 1 month of age and continue until surgical repair, which happens usually at 3 - 9 months of age.
Placebo will be given in a volume that corresponds to the patient's weight. Additionally, labeled syringes will be provided to families for accurate weight-based dosing. Treatment with placebo will begin at 1 month of age and continue until surgical repair, which happens usually at 3 - 9 months of age. There is no current standard of care for pharmacologic therapy for infants with ToF. As such, there are no alternative treatments, and the placebo group is standard of care.