Recruiting PHASE1 Tetralogy of Fallot

New treatment option for Tetralogy of Fallot

Official title Beta-blocker Administration for Cardiomyocyte Division

ClinicalTrials.gov ID: NCT04713657

What this study is testing

What is Propranolol Hydrochloride?

Propranolol Hydrochloride is an investigational medicine, being studied as a potential treatment for tetralogy of fallot.

Also referred to as Propranolol.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Heart failure is a common long-term complication in patients with congenital heart disease (CHD). Medical treatments to promote regeneration of new healthy heart muscle cells have the potential to provide new heart failure treatments for these patients.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 30 to 60

You may be able to join if

  • 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 variant

You likely can't join if

  • 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...
  • gestation age \< 35 weeks,
  • infants of diabetic mothers, asthma or underlying respiratory disease,
  • presence of metal implants in infants.

The study team makes the final eligibility decision.

Where it's taking place

  • New York, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 30 days to 60 days. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include New York, New York, United States; Philadelphia, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.