Your session is about to expire
← Back to Search
Beta-blocker
Propranolol for Congenital Heart Disease
Phase 1
Recruiting
Led By Bernhard Kuhn, MD
Research Sponsored by Bernhard Kuhn
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
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.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My infant has a specific heart condition, is under 45 days old, weighs more than 2 kg, and can tolerate feeding.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiomyocyte Division
Secondary outcome measures
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.
Find a Location
Who is running the clinical trial?
University of PittsburghOTHER
1,722 Previous Clinical Trials
16,342,906 Total Patients Enrolled
Bernhard KuhnLead Sponsor
Bernhard Kuhn, MDPrincipal Investigator - UPMC Children's Hospital of Pittsburgh
University of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are less than 35 weeks pregnant.My child was born to a diabetic mother or has asthma or another respiratory condition.My infant has a metal implant.You have a specific heart condition called congenital atrio-ventricular block, which can be seen on a heart test called an EKG.I am not taking any medications that interact with propranolol.My infant has a specific heart condition, is under 45 days old, weighs more than 2 kg, and can tolerate feeding.My condition is diagnosed as DORV.
Research Study Groups:
This trial has the following groups:- Group 1: Propranolol
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Propranolol been sanctioned by the FDA?
"There is scant clinical data to suggest the safety of Propranolol, so it received a rating of 1 on our scale."
Answered by AI
In what clinical circumstances is Propranolol typically prescribed?
"Propranolol is a popular medication for reducing cardiovascular mortality. Additionally, it can help patients manage various additional ailments such as angina pectoris, myocardial infarction and obstructive hypertrophic cardiomyopathy."
Answered by AI
Who is best suited to enroll in this scientific investigation?
"The parameters for admission to this research endeavour include having a diagnosis of tetralogy of Fallot and being between 29 days old and 2 months in age. The trial is seeking 40 participants."
Answered by AI
How many participants have been recruited to participate in this clinical research?
"At present, this medical trial is not recruiting new patients. It was first posted on August 15th 2022 and last updated July 5th 2022. For those searching for other studies, 13 trials involving tetralogy of fallot are currently enrolling participants and 41 clinical trials need volunteers who use Propranolol."
Answered by AI
Does this research endeavor have an age cap beyond which individuals cannot be involved?
"In agreement with the requirements for this experiment, only participants between 29 Days and 2 Months of age are eligible to join."
Answered by AI
Are any new participants being included in this research project?
"As per clinicaltrials.gov, the trial is not currently accepting participants. This medical study was initially posted on August 15th 2022 and last revised July 5th 2022. Despite this particular investigation being paused for now, 54 other studies are presently enrolling patients at large."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger