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Propranolol for Heart Muscle Growth in Infants with Congenital Heart Disease

This study is investigating if a medicine called Propranolol Hydrochloride can help increase the growth of new heart muscle cells in infants with certain congenital heart conditions, specifically Tetralogy of Fallot (ToF) or Double Outlet Right Ventricle (DORV). Researchers believe that increasing these cells could help prevent long-term heart failure. You can join if your infant is between 30 and 60 days old, weighs over 2 kg, and has one of these conditions. The study will measure heart muscle cell division at the time of surgical repair, which is expected around 3-9 months of age. The current recruitment status is unclear, and the study plans to enroll 40 participants.

Study design
This is an interventional study with 40 planned participants. It is testing Propranolol Hydrochloride against a control group, though the specific randomization or blinding is not detailed.
What's involved
Your child will receive 15N-thymidine in five separate syringes, and you'll keep a diary of their feeding and diaper changes for urine collection. They will also have an echocardiogram and a cardiac MRI (magnetic resonance imaging) at enrollment, and another echocardiogram before surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, cardiomyocyte division, is measured at the time of complete surgical repair, expected around 3-9 months of age.

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NCT04713657

Beta-blocker Administration for Cardiomyocyte Division

Recruiting
PHASE1Ages 30–60InterventionalTreatment
Weill Medical College of Cornell University
~40 participants
Updated 2025-11-18 on ClinicalTrials.gov
What's tested:N-thymidineUrine CollectionEchocardiogramCardiac MRI (CMR)Propranolol HydrochloridePlacebo

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cardiomyocyte Division
Measured over At the time of complete surgical repair, at approximately 3-9 months old, it is expected that a piece of RV myocardium will be resected. This tissue will be collected and analyzed using a multiple isotope mass spectrometer.

Conditions

Tetralogy of Fallot
Double Outlet Right Ventricle

Explore related trials

Double Outlet Right VentricleTetralogy of Fallot

Where it's being run

3 sites across 2 states
Pennsylvania2
New York1

Study leadership

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

Who to contact

Rashida Blackwood, BS, MPH
[email protected]
646-962-9036
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male and female infants \< 60 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

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.

What this trial measures

  • Cardiomyocyte DivisionAt the time of complete surgical repair, at approximately 3-9 months old, it is expected that a piece of RV myocardium will be resected. This tissue will be collected and analyzed using a multiple isotope mass spectrometer.

    To quantify cardiomyocyte division, investigators will utilize previously established MIMS (membrane introduction mass spectrometry) approach. Briefly, investigators will administer 5 enteral doses of 15N-thymidine to all patients at 1 month after birth. Cardiomyocytes that have undergone DNA replication after the intake of 15N-thymidine will incorporate the stable isotope into their DNA.