Using beta-blockers to promote heart muscle cell growth in infants with congenital heart defects
Official title: Mechanistic Clinical Trial of Beta-Blocker Administration For Reactivating Cardiomyocyte Division In Tetralogy of Fallot
Run by Weill Medical College of Cornell University · NCT04713657 · Data updated 2026-11-12
This study is testing if a heart medication called Propranolol can help heart muscle cells grow better in infants with certain congenital heart defects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 30 Days to 100 Days |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Status | Recruiting |
| Started | December 16, 2022 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT04713657 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are male and female infants under 45 days of age with a diagnosis of Tetralogy of Fallot or Double Outlet Right Ventricle who weigh more than 2 kg.
✕Probably not a fit
Patients with congenital atrio-ventricular block, certain respiratory diseases, or those unable to comply with study requirements may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of Propranolol, a beta-blocker, to enhance the proliferation of heart muscle cells in infants diagnosed with Tetralogy of Fallot or Double Outlet Right Ventricle. The study aims to understand how this medication can potentially normalize heart growth by examining discarded heart muscle tissue obtained during surgical procedures. By focusing on infants under 45 days of age, the trial seeks to provide insights into new treatment options for heart failure associated with congenital heart disease. The methodology includes various assessments such as echocardiograms and cardiac MRIs to monitor heart development.
Why it matters
Potential benefit: If successful, this treatment could lead to improved heart function and reduced long-term complications for infants with congenital heart defects.
How similar studies have gone: While the approach of using beta-blockers for heart muscle regeneration is novel, similar studies have shown promise in understanding heart cell proliferation in other contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female infants \< 100 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 Criteria: * 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, * Premature infants with corrected age \< 5 weeks, * asthma or underlying respiratory disease, * presence of metal implants in infants.
Where it's running
-
Columbia University Morgan Stanley Children'S Hospital
New York, New York, United States Recruiting -
Weill Cornell Medicine
New York, New York, United States Recruiting -
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Recruiting -
Upmc Children'S Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Bernhard Kuhn, MD — Weill Medical College of Cornell University
- Study coordinator: Rashida Blackwood, BS, MPH
- Email: rab4029@med.cornell.edu
- Phone: 646-962-9036
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Early versus later corrective surgery for newborns with Tetralogy of Fallot.
This trial will test whether doing corrective heart surgery within the first 28 days or waiting until 3–6 months leads to better outcomes for newborns with Tetralogy of Fallot.
-
High intensity interval training for patients with congenital heart defects
This study is testing if a 12-week home workout program can help young people with certain heart defects exercise better and feel stronger.
-
Effects of stenting on exercise capacity in patients with certain congenital heart defects
This study is testing if a procedure to open blocked arteries can help people with certain heart defects, like d-TGA, ToF, and TA, exercise better.
-
Registry for patients with repaired Tetralogy of Fallot
This study is collecting information from patients who have had surgery for Tetralogy of Fallot to see how their hearts are doing over time using special imaging tests.
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How transcatheter pulmonary valves interact with electrical pathways in repaired Tetralogy of Fallot
This project will test if detailed right-ventricular electrical mapping before transcatheter pulmonary valve replacement can find conduction isthmuses that might be 'jailed' and linked to ventricular tachycardia in people with repaired Tetralogy of Fallot.
-
Understanding heart issues in patients with congenital heart disease
This study is trying to understand what causes symptoms like shortness of breath and palpitations in people with congenital heart disease, especially those with Tetralogy of Fallot, by using remote heart monitoring.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.