High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit

Launched by ERASMUS MEDICAL CENTER · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a type of exercise called high intensity interval training (HIIT) can help improve exercise ability in young people with specific congenital heart conditions. These conditions include those who have had surgery to create a connection between the right ventricle (the heart chamber that pumps blood to the lungs) and the pulmonary artery. The trial is open to individuals aged 12 to 45 years who are currently being followed at specialized heart centers. To participate, individuals must have a diagnosis related to these heart defects and provide consent to join the study.

Participants in the trial will engage in a 12-week exercise program that they can do at home, working out three times a week for about 30 minutes each session, with guidance provided digitally. They will also attend a few study visits where they will undergo various tests to monitor their heart health and overall well-being. The study will compare the progress of those who participate in the exercise program to those who will start it later, helping researchers understand the benefits and any factors that may affect how well individuals respond to this type of training. This research could provide valuable insights into improving the quality of life and physical fitness for people with these heart conditions.

Gender

ALL

Eligibility criteria

• 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.