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

Oslo University Hospital76 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Heart Disease

Eligibility

Sex: ALLMin age: 15 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology

Oslo, Norway

Outcomes

Primary Outcomes

Hemodynamic status

Status as found by invasive and non-invasive assessment

Time frame: Current at time of inclusion

Structural and functional hepatic changes

Status as found by non-invasive assessment

Time frame: Current at time of inclusion

Cardio-pulmonary function and functional reserve

Status as found by non-invasive assessment

Time frame: Current at time of inclusion

Quality of life and psycho-social outcome

Status as found by questionnaire

Time frame: Current at time of inclusion

Data from ClinicalTrials.gov

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