Beta-blocker Administration for Cardiomyocyte Division

Last updated: August 5, 2024
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Recruiting

Phase

1

Condition

Heart Defect

Pentalogy Of Cantrell

Treatment

Urine Collection

Echocardiogram

N-thymidine

Clinical Study ID

NCT04713657
23-12026881
R01HL155597
  • Ages 30-44
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Male and female infants < 45 days of age with a diagnosis of tetralogy of Fallotwith pulmonary stenosis or double outlet right ventricle, tetralogy type byechocardiogram, who weigh greater than 2 kg at the time of consent and aretolerating enteral feeds.

  • DORV variant

Exclusion

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 therequirements 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.

Study Design

Total Participants: 40
Treatment Group(s): 8
Primary Treatment: Urine Collection
Phase: 1
Study Start date:
December 16, 2022
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Upmc Children'S Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

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