Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects

University of Oslo (UIO)

Status: Completed

Conditions: Congenital Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02378857

2014077 (Other Identifier)

2013/1331 (REK)

Details and patient eligibility

About

Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.

Full description

A study group of 40-50 individuals will be investigated by non-invasive and invasive methods, including echocardiography at rest and during exercise, heart catheterization with advanced hemodynamic studies, cardiac and abdominal MRI, abdominal ultrasound and transient elastography, quality of life assessment and cardiopulmonary exercise testing. A selection of tests will be performed in a healthy control group as well.

Enrollment: 76 patients

Sex: All

Ages: 15 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age, heart defect, heart surgery and type of palliation/correction, informed consent

Exclusion criteria

• non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)

Trial design

76 participants in 2 patient groups

Patient group

Description:

Adolescents (15-18 years of age) With univentricular heart defects and Fontan type palliation.

Control group

Description:

Age- and gender-matched healthy individuals