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NCT04713657PHASE1Recruiting

Beta-blocker Administration for Cardiomyocyte Division

Weill Medical College of Cornell University

Start Date

12/16/2022

Completion Date

12/31/2030

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * 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 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, * infants of diabetic mothers, asthma or underlying respiratory disease, * presence of metal implants in infants.

Interventions

OTHER

N-thymidine

OTHER

Urine Collection

PROCEDURE

Echocardiogram

PROCEDURE

Cardiac MRI (CMR)

DRUG

Propranolol Hydrochloride

DRUG

Placebo

PROCEDURE

Physical Exam

OTHER

Specimen Collection

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Conditions

Tetralogy of FallotDouble Outlet Right Ventricle

Locations

Weill Cornell Medicine

New York, New York 10065

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Upmc Children'S Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States