Actively Recruiting
Beta-blocker Administration for Cardiomyocyte Division
Led by Weill Medical College of Cornell University · Updated on 2025-11-18
40
Participants Needed
3
Research Sites
419 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Beta-blocker Administration for Cardiomyocyte Division
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female infants younger than 60 days with Tetralogy of Fallot with pulmonary stenosis or Double Outlet Right Ventricle, tetralogy type, confirmed by echocardiogram
- Infant weighs more than 2 kilograms at consent
- Infant is tolerating feeding by mouth
You will not qualify if you...
- Congenital atrio-ventricular block on EKG (PR interval greater than 120 ms)
- Taking medications that interact with propranolol
- Investigator believes family cannot comply with study requirements or infant is unsuitable
- Gestational age less than 35 weeks
- Infant of a diabetic mother
- Infant has asthma or underlying respiratory disease
- Presence of metal implants in infant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
Upmc Children'S Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
R
Rashida Blackwood, BS, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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