Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
- Conditions
- Congenital Heart Disease
- Registration Number
- NCT02378857
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- age, heart defect, heart surgery and type of palliation/correction, informed consent
- non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life and psycho-social outcome Current at time of inclusion Status as found by questionnaire
Hemodynamic status Current at time of inclusion Status as found by invasive and non-invasive assessment
Structural and functional hepatic changes Current at time of inclusion Status as found by non-invasive assessment
Cardio-pulmonary function and functional reserve Current at time of inclusion Status as found by non-invasive assessment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology
🇳🇴Oslo, Norway