congenital heart disease. heart defects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Surgical repair for Tetralogy of Fallot through transatrial-transpulmonary repair, below the age of 2 years, or - Surgical repair for single ventricle physiology, with intracardiac or extracardiac tunnel, performed before the age of 6 years as a (at least) 2-stage procedure (previous partial cavopulmonary repair), - Age at inclusion at least 10 years of age, - Being followed in Erasmus MC, LUMC, UMC St Radboud, UMCU Wilhelmina Children*s Hospital,
Exclusion criteria
Exclusion criteria: - Inability to exercise - Mental retardation - Standard contra-indications for MRI - Ventricular outflow obstruction (peak Doppler gradient > 60 mm Hg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) measures of aerobic fitness (all patients): oxygen uptake peak power in last half minute of graded bicycle ergometer test, b) measures of cardiac function; Fallot group: end-systolic right ventricle end-diastolic volume right ventricle ejection fraction of right ventricle end-systolic left ventricle end-diastolic volume left ventricle ejection fraction of left ventricle NT-proBNP level Fontan group: end-systolic single ventricle end-diastolic volume single ventricle ejection fraction of single ventricle NT-proBNP level c) measures of daily physical activity: percentage of day during which dynamic activities have been performed; average motility (as assessed by means of an Activity Monitor) d) health related quality of life, as assessed with questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| None | — |
Countries
Netherlands