Actively Recruiting
High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
Led by Erasmus Medical Center · Updated on 2026-01-21
38
Participants Needed
2
Research Sites
193 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
D
Dutch Heart Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery requiring surgical implantation of a conduit, including truncus arteriosus, pulmonary atresia with ventricular septal defect, severe tetralogy of Fallot, or other forms of pulmonary atresia with biventricular correction
- Age 12 to 45 years
- Current follow-up in Academic Center for Congenital Heart Disease (ACAHA) at Erasmus MC Rotterdam or Radboudumc Nijmegen
- Signed informed consent
You will not qualify if you...
- Ventricular arrhythmias and/or channelopathy
- Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes
- Left or right ventricular ejection fraction less than 30 percent
- Elite athletes exercising 10 or more hours per week (national team, Olympians, professionals)
- Cardiovascular lesions requiring intervention
- Cardiovascular intervention (surgery or catheterization) less than 6 months ago
- Cardiovascular medication changes less than 3 months ago
- Hospitalization for cardiovascular events less than 6 months ago
- Comorbidities or developmental delay impairing exercise training (e.g., neuromuscular disease, symptomatic myocardial ischemia, trisomy 21)
- Inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Not Yet Recruiting
2
ErasmusMC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
A
Anouk S Moerdijk, MD
CONTACT
B
Beatrijs Bartelds, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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