Fontan Study (Observational)

Fontan studied the relationship between functional health status and laboratory parameters of ventricular performance after the Fontan Procedure. This study was done to survey the health status of patients after Fontan surgery and to better understand how tests performed routinely to evaluate heart function relate to overall health status in patients after Fontan surgery. 546 people participated in the study.

Who was in the study?

People in the study:
  • Were 6-18 years of age
  • Had the Fontan surgery at least 6 months before entry into the study
  • Were not pregnant

What happened during the study?

Each qualified person completed the following study procedures:
  • Health status questionnaire (parents and children 10 years old and older)
  • Echocardiogram
  • Blood sample
  • Cardiac MRI (magnetic resonance imaging)
  • Exercise Testing 

What were the results of the study?

Here are some things that we learned about Fontan patients as a group:
  • The health surveys showed that, although the average score for the Fontan patient was lower than the average score in children without congenital heart disease, 81% of Fontan patients scored in the normal range for physical functioning and 87% were in the normal range for mental functioning.
  • We found that children in the study did not perform as well on the bicycle exercise test as children without congenital heart disease and that younger children in the study did better than older children.
The things we learned may not apply to every child. The findings reflect those for all 546 people who participated. Individual results varied quite a bit. Important information from echocardiograms on almost all of the patients and cardiac MRI on about 200 patients is being studied now.The PHN is grateful to all of the families who participated in this study. The results from this study will help us to design future studies to learn more about helping children who had Fontan surgery live healthier lives.