Beta-blocker Administration for Cardiomyocyte Division

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jan 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called Propranolol can help increase the growth of new heart muscle cells in infants with certain types of heart defects, specifically Tetralogy of Fallot or Double Outlet Right Ventricle. These conditions can lead to heart failure later in life, and the researchers hope that by promoting the growth of healthy heart muscle, they can improve long-term heart health for these children. The trial is currently recruiting participants who are infants under 45 days old, weigh more than 2 kg, and are able to take regular feeding.

Participants in the study will have their heart tissue examined during surgery to see if Propranolol helps generate new heart muscle cells. While Propranolol is already approved for treating a type of benign tumor in infants, its use for heart muscle growth is being explored for the first time. If you think your child might be eligible, it’s important to discuss this study with your healthcare provider to understand the benefits and any potential risks involved.

Gender

ALL

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.
• • 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.