Using beta-blockers to promote heart muscle cell growth in infants with congenital heart defects
Mechanistic Clinical Trial of Beta-Blocker Administration For Reactivating Cardiomyocyte Division In Tetralogy of Fallot
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 |
| Enrollment | 40 (estimated) |
| Ages | 30 Days to 60 Days |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT04713657 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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, * gestation age \< 35 weeks, * infants of diabetic mothers, asthma or underlying respiratory disease, * presence of metal implants in infants.
Where this trial is running
New York, New York and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.