Fontan Procedure Physiology Study

Do Serum Biochemical and Hematopoietic, or Stool Biomarkers Predict Low Cardiac Index in Patients with Fontan Physiology?

Protocol Description

This multicenter study is being done to determine whether chemical markers in blood, urine, and stool can serve as early indicators for worsening heart function in patients who have had a Fontan procedure. This is an important step towards developing interventions to improve quality of life and overall functioning in individuals who have had this procedure. Fontan surgery involves diverting venous blood from the right atrium to the pulmonary arteries without passing through the right ventricle. It is sometimes done in pediatric cases as treatment for heart valve defects such as tricuspid atresia or pulmonary atresia, or for a pumping abnormality such as hypoplastic left heart syndrome or hypoplastic right heart syndrome.

Eligibility Criteria

This study is open to men and women ages 18 through 40 who are being followed at the Adult Congenital Heart Disease Center of Children’s Hospital of Pittsburgh of UPMC and who had a Fontan surgery at least 4 years prior or a Fontan revision or conversion at least 1 year prior. 
Males and Females: Ages 18 through 40

Requirements

During a single visit, medical records will be reviewed and participants will need to complete questionnaires about their health, physical activity, mental health and quality of life. Various body measurements will be taken and additional tests will be done using electrocardiogram, cardiac magnetic resonance imaging, and collection of blood, urine, and stool samples.
Visits: A single 6-hour visit
Duration: Not applicable

Status: Open to Enrollment

Source(s) of Support

Cincinnati Children’s Hospital Medical Center

Contact Information

For more information about the study or enrollment, please contact:
Morgan LeSuer-Mandernack, study coordinator
412-692-6516