An interventional study of High intensity interval training in Congenital Heart Disease, Truncus Arteriosus and Pulmonary Atresia, sponsored by Erasmus Medical Center. Recruiting at 2 sites in Netherlands. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn if a specific type of exercise training (high intensity interval training) can improve exercise capacity in people with a congenital heart defect that required the creation of a new connection between the right ventricle and pulmonary artery. This includes people with a truncus arteriosus, pulmonary atresia with a ventricular septal defect or severe tetralogy of Fallot. This study focuses on people aged 12 to 45 years. The main questions it aims to answer are:
Researchers will compare the results from the intervention group to the control group. Participants will be assigned to one of these two groups at inclusion. The control group will also receive the intervention, after the control period.
Participants will:
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's planned enrollment of 38 is below the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with:
Exclusion Criteria:
This arm receives the 12-week exercise intervention, with a study visit before and after the intervention.
Behavioral: High intensity interval training
This arm starts with a 12-week control period, after which the participants will also receive the 12-week exercise intervention. Participants will have a study visit before and after the control period and after the intervention. For the primary outcome parameter, only the control period will be used to compare to the intervention. For the secondary outcome parameters (predictors for response), also the intervention period of the control group will be used.
A 12-week high intensity interval training program, with 30 minutes of exercise three times a week. The trainings can be completed at home and will be digitally supervised.
Peak oxygen consumption
Peak oxygen consumption obtained with CPET
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Maximum wattage
Maximum wattage obtained with CPET
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Heart rate recovery
Heart rate recovery obtained with CPET
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Ventilatory efficiency slope
Ventilatory efficiency slope obtained with CPET
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Atrial volumes
Atrial volumes obtained with echocardiography
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Left and right ventricular inflow pattern
Left and right ventricular inflow pattern obtained with echocardiography (E and A waves)
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular size
Ventricular size obtained with echocardiography
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Left and right ventricular ejection fraction
Left ventricular ejection fraction obtained with echocardiography
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Right ventricular fractional area change
Right ventricular fractional area change obtained with echocardiography
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Tricuspid annular plane systolic excursion (TAPSE)
TAPSE obtained with echocardiography
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular strain
Ventricular strain obtained with echocardiography
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Vascular flow
Vascular flow (aortic valve, RV-PA conduit, mitral and tricuspid valve) obtained with echocardiography
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular size
Ventricular size obtained with MRI
Time frame: At baseline, week 14 and week 27 (control arm only)
Right and left ventricular ejection fraction
Right and left ventricular ejection fraction obtained with MRI
Time frame: At baseline, week 14 and week 27 (control arm only)
Ventricular mass
Ventricular mass obtained with MRI
Time frame: At baseline, week 14 and week 27 (control arm only)
Vascular flow
Two-dimensional phase-contrast flow in the aorta and main pulmonary artery, obtained with MRI
Time frame: At baseline, week 14 and week 27 (control arm only)
Ventricular kinetic energy
Ventricular kinetic energy obtained with four-dimensional flow MRI
Time frame: At baseline, week 14 and week 27 (control arm only)
NT-proBNP
NT-proBNP in blood
Time frame: At baseline, week 14 and week 27 (control arm only)
GDF-15
GDF-15 in blood
Time frame: At baseline, week 14 and week 27 (control arm only)
Soluble ST-2
Soluble ST-2 in blood
Time frame: At baseline, week 14 and week 27 (control arm only)
Galectin-3
Galectin-3 in blood
Time frame: At baseline, week 14 and week 27 (control arm only)
Gut microbiome composition
Gut microbiome composition analyzed using 16S rRNA sequencing in fecal samples
Time frame: At baseline, week 14 and week 27 (control arm only)
Changes in weight
Changes in weight (kg) and derivatives such as BMI (weight / height\^2, reported in kg/m\^2)
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Time in moderate-to-vigorous and sedentary activity
Average time per day and total time (minutes and percentage), measured by accelerometry with the Actigraph waist accelerometer worn for seven days
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Time in moderate-to-vigorous and sedentary activity
Measured using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH) questionnaire
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life (child perspective)
Measured by Child Health Questionnaire (CHQ) Child Form (CF) (CHQ-CF45) for participants aged under 18 years, scale 0-100 (100 being the best outcome)
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life (parent perspective)
Measured by Child Health Questionnaire (CHQ) Parent Form (PF) (CHQ-PF28) for participants aged under 18 years, scale 0-100 (100 being the best outcome)
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life
Measured by the 36-Item Short Form Health Survey (SF-36) questionnaire for participants aged over 18 years, scale 0-100 (100 being the best outcome)
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Fatigue-related quality of life
Measured by the PedsQL Multidimensional Fatigue Scale for all participants, scale 0-100 (100 being the best outcome)
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Plan to share: No
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