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| Name | Class |
|---|---|
| Dutch Heart Foundation | OTHER |
| Radboud University Medical Center | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This arm receives the 12-week exercise intervention, with a study visit before and after the intervention. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity interval training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen consumption | Peak oxygen consumption obtained with CPET | At baseline, week 14, week 27 (control arm only) and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum wattage | Maximum wattage obtained with CPET | At baseline, week 14, week 27 (control arm only) and 1 year |
| Heart rate recovery | Heart rate recovery obtained with CPET |
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Inclusion Criteria:
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:
Age 12 to 45 years.
Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).
Signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anouk S Moerdijk, MD | Contact | +31107036264 | a.moerdijk@erasmusmc.nl | |
| Beatrijs Bartelds, MD, PhD | Contact | +31107036264 | b.bartelds@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Beatrijs Bartelds, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Not yet recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114665 | Derived | Moerdijk AS, van Genuchten WJ, Duijnhouwer AL, Snoeren MMM, Hirsch A, van den Berg LEM, Boersma E, Kauling RM, van den Bosch AE, Udink Ten Cate FEA, Helbing WA, Bartelds B. Evaluation of high intensity interval training in patients with a right ventricle to pulmonary artery conduit in a randomized controlled trial: Rationale and design of the "Right HIIT" study. Am Heart J. 2026 Sep;299:107477. doi: 10.1016/j.ahj.2026.107477. Epub 2026 May 21. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D014339 | Truncus Arteriosus, Persistent |
| D018633 | Pulmonary Atresia |
| D013771 | Tetralogy of Fallot |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Participants will be randomized into the intervention or control arm. After the control period, participants in the control arm will also receive the intervention.
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| At baseline, week 14, week 27 (control arm only) and 1 year |
| Ventilatory efficiency slope | Ventilatory efficiency slope obtained with CPET | At baseline, week 14, week 27 (control arm only) and 1 year |
| Atrial volumes | Atrial volumes obtained with echocardiography | 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) | At baseline, week 14, week 27 (control arm only) and 1 year |
| Ventricular size | Ventricular size obtained with echocardiography | 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 | 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 | At baseline, week 14, week 27 (control arm only) and 1 year |
| Tricuspid annular plane systolic excursion (TAPSE) | TAPSE obtained with echocardiography | At baseline, week 14, week 27 (control arm only) and 1 year |
| Ventricular strain | Ventricular strain obtained with echocardiography | 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 | At baseline, week 14, week 27 (control arm only) and 1 year |
| Ventricular size | Ventricular size obtained with MRI | 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 | At baseline, week 14 and week 27 (control arm only) |
| Ventricular mass | Ventricular mass obtained with MRI | 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 | At baseline, week 14 and week 27 (control arm only) |
| Ventricular kinetic energy | Ventricular kinetic energy obtained with four-dimensional flow MRI | At baseline, week 14 and week 27 (control arm only) |
| NT-proBNP | NT-proBNP in blood | At baseline, week 14 and week 27 (control arm only) |
| GDF-15 | GDF-15 in blood | At baseline, week 14 and week 27 (control arm only) |
| Soluble ST-2 | Soluble ST-2 in blood | At baseline, week 14 and week 27 (control arm only) |
| Galectin-3 | Galectin-3 in blood | At baseline, week 14 and week 27 (control arm only) |
| Gut microbiome composition | Gut microbiome composition analyzed using 16S rRNA sequencing in fecal samples | 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) | 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 | 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 | 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) | 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) | 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) | 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) | At baseline, week 14, week 27 (control arm only) and 1 year |
| ErasmusMC | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001028 | Aortopulmonary Septal Defect |
| D006343 | Heart Septal Defects |
| D054079 | Vascular Malformations |
| D006349 | Heart Valve Diseases |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |