Congenital Heart Disease, Pulmonary Atresia, Tetralogy of Fallot, Truncus Arteriosus
Conditions
Keywords
Heart Defects, Congenital, Truncus Arteriosus, Persistent, Pulmonary Atresia, Tetralogy of Fallot, Physical Conditioning, Human, High-Intensity Interval Training, Exercise Test
Brief summary
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: * Can a 12-week home-based high intensity interval exercise training program increase the exercise capacity? * Can factors that predict whether or not the exercise training program can increase the exercise capacity in specific people be identified? 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: * Participate in a 12-week home-based exercise training program (3x30 minutes a week, digitally supervised); * Attend 2 or 3 study visits (which partially is standard care) (2 visits for the intervention group, 3 visits for the control group); * Each study visit includes: echocardiography, magnetic resonance imaging (MRI) of the heart, cardiopulmonary exercise testing (CPET), blood and feces sampling, and questionnaires on quality of life and physical activity.
Interventions
BEHAVIORALHigh intensity interval training
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.
Sponsors
Erasmus Medical Center
Dutch Heart Foundation
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized into the intervention or control arm. After the control period, participants in the control arm will also receive the intervention.
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. 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: 1. Truncus arteriosus 2. Pulmonary atresia with ventricular septum defect 3. Severe tetralogy of Fallot 4. Other forms of pulmonary atresia with biventricular correction 2. Age 12 to 45 years. 3. Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen). 4. Signed informed consent.
Exclusion criteria
1. Ventricular arrhythmias and/or channelopathy. 2. Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes. 3. Left ventricular ejection fraction and/or right ventricular ejection fraction less than 30 percent. 4. Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h/week, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease). 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 | Description |
|---|---|---|
| Peak oxygen consumption | At baseline, week 14, week 27 (control arm only) and 1 year | Peak oxygen consumption obtained with CPET |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum wattage | At baseline, week 14, week 27 (control arm only) and 1 year | Maximum wattage obtained with CPET |
| Heart rate recovery | At baseline, week 14, week 27 (control arm only) and 1 year | Heart rate recovery obtained with CPET |
| Ventilatory efficiency slope | At baseline, week 14, week 27 (control arm only) and 1 year | Ventilatory efficiency slope obtained with CPET |
| Atrial volumes | At baseline, week 14, week 27 (control arm only) and 1 year | Atrial volumes obtained with echocardiography |
| Left and right ventricular inflow pattern | At baseline, week 14, week 27 (control arm only) and 1 year | Left and right ventricular inflow pattern obtained with echocardiography (E and A waves) |
| Ventricular size | At baseline, week 14, week 27 (control arm only) and 1 year | Ventricular size obtained with echocardiography |
| Left and right ventricular ejection fraction | At baseline, week 14, week 27 (control arm only) and 1 year | Left ventricular ejection fraction obtained with echocardiography |
| Right ventricular fractional area change | At baseline, week 14, week 27 (control arm only) and 1 year | Right ventricular fractional area change obtained with echocardiography |
| Tricuspid annular plane systolic excursion (TAPSE) | At baseline, week 14, week 27 (control arm only) and 1 year | TAPSE obtained with echocardiography |
| Ventricular strain | At baseline, week 14, week 27 (control arm only) and 1 year | Ventricular strain obtained with echocardiography |
| Vascular flow | At baseline, week 14, week 27 (control arm only) and 1 year | Vascular flow (aortic valve, RV-PA conduit, mitral and tricuspid valve) obtained with echocardiography |
| Right and left ventricular ejection fraction | At baseline, week 14 and week 27 (control arm only) | Right and left ventricular ejection fraction obtained with MRI |
| Ventricular mass | At baseline, week 14 and week 27 (control arm only) | Ventricular mass obtained with MRI |
| Ventricular kinetic energy | At baseline, week 14 and week 27 (control arm only) | Ventricular kinetic energy obtained with four-dimensional flow MRI |
| NT-proBNP | At baseline, week 14 and week 27 (control arm only) | NT-proBNP in blood |
| GDF-15 | At baseline, week 14 and week 27 (control arm only) | GDF-15 in blood |
| Soluble ST-2 | At baseline, week 14 and week 27 (control arm only) | Soluble ST-2 in blood |
| Galectin-3 | At baseline, week 14 and week 27 (control arm only) | Galectin-3 in blood |
| Gut microbiome composition | At baseline, week 14 and week 27 (control arm only) | Gut microbiome composition analyzed using 16S rRNA sequencing in fecal samples |
| Changes in weight | At baseline, week 14, week 27 (control arm only) and 1 year | Changes in weight (kg) and derivatives such as BMI (weight / height\^2, reported in kg/m\^2) |
| Time in moderate-to-vigorous and sedentary activity | At baseline, week 14, week 27 (control arm only) and 1 year | Average time per day and total time (minutes and percentage), measured by accelerometry with the Actigraph waist accelerometer worn for seven days |
| Quality of life (child perspective) | At baseline, week 14, week 27 (control arm only) and 1 year | 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) |
| Quality of life (parent perspective) | At baseline, week 14, week 27 (control arm only) and 1 year | 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) |
| Quality of life | At baseline, week 14, week 27 (control arm only) and 1 year | 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) |
| Fatigue-related quality of life | At baseline, week 14, week 27 (control arm only) and 1 year | Measured by the PedsQL Multidimensional Fatigue Scale for all participants, scale 0-100 (100 being the best outcome) |
Countries
Netherlands
Contacts
CONTACTAnouk S Moerdijk, MD
CONTACTBeatrijs Bartelds, MD, PhD
PRINCIPAL_INVESTIGATORBeatrijs Bartelds, MD, PhD
Erasmus Medical Center
Outcome results
None listed