High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit (NCT06771687) | Clinical Trial Compass
RecruitingNot Applicable
High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
Netherlands38 participantsStarted 2025-01-16
Plain-language 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.
Who can participate
Age range
12 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. Truncus arteriosus
. Pulmonary atresia with ventricular septum defect
. Severe tetralogy of Fallot
. Other forms of pulmonary atresia with biventricular correction
. Age 12 to 45 years.
. Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak oxygen consumption
Timeframe: At baseline, week 14, week 27 (control arm only) and 1 year
. Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.
. Left ventricular ejection fraction and/or right ventricular ejection fraction less than 30 percent.
. 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).
. Cardiovascular lesions requiring intervention (according to international guidelines).
. Cardiovascular intervention (surgery or catheterization) less than 6 months ago.
. Cardiovascular medication changes less than 3 months ago.
. Hospitalization for treatment of cardiovascular events less than 6 months ago.