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Beta-blocker

Propranolol for Congenital Heart Disease

Phase 1

Recruiting

Led By Bernhard Kuhn, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be younger than 18 years old

Must not have

Presence of metal implants in infants

Concomitant medication administration that interacts with propranolol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Summary

This trial is testing whether a medicine called Propranolol can help people with congenital heart disease by increasing the growth of new heart muscle cells.

Who is the study for?

This trial is for male and female infants under 45 days old with specific heart conditions (Tetralogy of Fallot or double outlet right ventricle) who weigh over 2 kg and can tolerate feeding by mouth. It's not for babies born before 35 weeks, those with certain EKG results, on medications that affect propranolol, have diabetic mothers, respiratory issues, or metal implants.

What is being tested?

The study tests if Propranolol can help grow new heart muscle cells in infants with congenital heart disease. It involves a comparison between Propranolol and a placebo while monitoring through cardiac MRI, echocardiograms, urine collection, physical exams and specimen collection from surgery.

What are the potential side effects?

Propranolol may cause low blood sugar levels especially in infants of diabetic mothers), slow heartbeat (which could be risky given the pre-existing heart conditions), breathing difficulties (not suitable for those with asthma/respiratory diseases), and interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My infant has a specific heart condition, is under 45 days old, weighs more than 2 kg, and can tolerate feeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has a metal implant.

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I am not taking any medications that interact with propranolol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiomyocyte Division

Secondary study objectives

Hypertrophy as assessed by Cardiac MR

Hypertrophy as assessed by echocardiography

Hypertrophy assessed by microscopy

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PropranololActive Control7 Interventions

The target dose of Propranolol hydrochloride for this study target dose for this study will be 4 mg/kg/day divided in 4 doses. The concentration of propranolol solution is 20 mg/5 mL. Additionally, labeled syringes will be provided to families for accurate weight-based dosing. Treatment with propranolol will begin at 1 month of age and continue until surgical repair, which happens usually at 3 - 9 months of age.

Group II: PlaceboPlacebo Group7 Interventions

Placebo will be given in a volume that corresponds to the patient's weight. Additionally, labeled syringes will be provided to families for accurate weight-based dosing. Treatment with placebo will begin at 1 month of age and continue until surgical repair, which happens usually at 3 - 9 months of age. There is no current standard of care for pharmacologic therapy for infants with ToF. As such, there are no alternative treatments, and the placebo group is standard of care.

0 / 3Eligibility criteria met