Beta-blocker Administration for Cardiomyocyte Division

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Tetralogy of Fallot, Double Outlet Right Ventricle

In brief

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.

Key facts

Study ID

NCT04713657

Run by

Weill Medical College of Cornell University

People needed

40

Starts

2022-12-16

Expected to finish

2030-12-31

Last updated by the study team

2025-11-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Upmc Children'S Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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