RECRUITING

Beta-blocker Administration for Cardiomyocyte Division

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanistic Clinical Trial of Beta-Blocker Administration For Reactivating Cardiomyocyte Division In Tetralogy of Fallot

Quick Facts

Study Start:2022-12-16
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04713657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Days to 44 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * DORV variant
  1. * congenital atrio-ventricular block on EKG (PR interval \> 120 ms),
  2. * concomitant medication administration that interacts with propranolol,
  3. * 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,
  4. * gestation age \< 35 weeks,
  5. * infants of diabetic mothers, asthma or underlying respiratory disease,
  6. * presence of metal implants in infants.

Contacts and Locations

Study Contact

Rashida Blackwood, BS, MPH
CONTACT
646-962-9036
rab4029@med.cornell.edu

Principal Investigator

Bernhard Kuhn, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10065
United States
Upmc Children'S Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Bernhard Kuhn, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-16
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2022-12-16
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Tetralogy of Fallot
  • Double Outlet Right Ventricle

Additional Relevant MeSH Terms

  • Tetralogy of Fallot
  • Double Outlet Right Ventricle