Congenital Heart Disease
Conditions
Interventions
12-week high intensity interval training program, semi-supervised (online),
three times a week.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of an RV-PA conduit, including patients with: a. Truncus arteriosus b. Pulmonary atresia with ventricular septum defect c. Severe tetralogy of Fallot d. Other forms of pulmonary atresia with biventricular correction 2. Age 12 to 45 years. 3. Current follow-up in ACAHA. 4. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Ventricular arrhythmias and/or channelopathy. 2. ICD implanted due to inherited arrhythmia syndromes 3. Left ventricular ejection fraction (LV EF) and/or right ventricular ejection fraction (RV EF) =10 h/week, according to definition in 2020 ESC Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease).(37) 5. Cardiovascular lesions requiring intervention (according to international guidelines) 6. Cardiovascular intervention (surgery or catheterization) less than 6 months ago. 7. Cardiovascular medication changes less than 3 months ago. 8. Hospitalization for treatment of cardiovascular events less than 6 months ago. 9. Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21). 10. Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak oxygen consumption measured by CPET. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Other measures of exercise capacity: measured by CPET (including maximum wattage, ventilatory efficiency slope, heart rate recovery, ventilatory thresholds) • Cardiovascular dimensions and function: o Echocardiographic parameters * Standard echocardiographic parameters indicating ventricular and valvular size and function (as described in echocardiography guidelines) o MRI parameters * Ventricular size, mass, mass-volume ratio, function (ejection fraction), flow measurements in the aorta and main pulmonary artery (2D and 4D), pulmonary regurgitation fraction, right and left ventricular and systemic and pulmonary vascular kinetic energy • Blood biomarkers o Commonly used biomarkers in CHD such as NT-proBNP, proteomics (including GDF-15) and non-coding RNA for identification of predictors of response to exercise training • Gut microbiome composition • Anthropometric measurements: changes in weight (and derivatives such as BMI, BSA) • Daily physical activity (measured using accelerometry with wearables, provided on each visit and worn for the following seven days) • Quality of life: measured by age-appropriate questionnaires (CHQ-CF45 and CHQ-PF28 for participants aged under 18 years, SF-36 for participants aged over 18 years and PedsQL MFS for all participants) | — |
Countries
Netherlands
Outcome results
None listed