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Beta-blocker Administration for Cardiomyocyte Division

RecruitingPhase 1Ages 30 Days - 100 DaysAllWeill Medical College of Cornell University
NCT04713657 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male and female infants \< 100 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, * Premature infants with corrected age \< 5 weeks, * asthma or underlying respiratory disease, * presence of metal implants in infants.
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What it tests

  • N-thymidine
  • Urine Collection
  • Echocardiogram
  • Cardiac MRI (CMR)
  • Propranolol Hydrochloride
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Where

4 sites
Columbia University Morgan Stanley Children'S Hospital
New York, United States
Weill Cornell Medicine
New York, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Upmc Children'S Hospital of Pittsburgh
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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