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

Erasmus Medical Center2 sites in 1 country38 target enrollmentJanuary 16, 2025

ConditionsCongenital Heart Disease Truncus Arteriosus Pulmonary Atresia Tetralogy of Fallot

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Congenital Heart Disease
Sponsor: Erasmus Medical Center
Enrollment: 38
Locations: 2
Primary Endpoint: Peak oxygen consumption
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 16, 2025

End Date

October 1, 2028

Last Updated

3 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Erasmus Medical Center

Responsible Party

Principal Investigator

Beatrijs Bartelds

Principal investigator, pediatric cardiologist, associate professor

Erasmus Medical Center

Eligibility Criteria

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).
•Signed informed consent.

Exclusion Criteria

•Ventricular arrhythmias and/or channelopathy.
•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.
•Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21).
•Inability to provide informed consent.

Outcomes

Primary Outcomes

Peak oxygen consumption

Time Frame: At baseline, week 14, week 27 (control arm only) and 1 year

Peak oxygen consumption obtained with CPET

Secondary Outcomes

GDF-15(At baseline, week 14 and week 27 (control arm only))
Maximum wattage(At baseline, week 14, week 27 (control arm only) and 1 year)
Heart rate recovery(At baseline, week 14, week 27 (control arm only) and 1 year)
Ventilatory efficiency slope(At baseline, week 14, week 27 (control arm only) and 1 year)
Atrial volumes(At baseline, week 14, week 27 (control arm only) and 1 year)
Left and right ventricular inflow pattern(At baseline, week 14, week 27 (control arm only) and 1 year)
Ventricular size(At baseline, week 14 and week 27 (control arm only))
Left and right ventricular ejection fraction(At baseline, week 14, week 27 (control arm only) and 1 year)
Right ventricular fractional area change(At baseline, week 14, week 27 (control arm only) and 1 year)
Tricuspid annular plane systolic excursion (TAPSE)(At baseline, week 14, week 27 (control arm only) and 1 year)
Ventricular strain(At baseline, week 14, week 27 (control arm only) and 1 year)
Vascular flow(At baseline, week 14 and week 27 (control arm only))
Right and left ventricular ejection fraction(At baseline, week 14 and week 27 (control arm only))
Ventricular mass(At baseline, week 14 and week 27 (control arm only))
Ventricular kinetic energy(At baseline, week 14 and week 27 (control arm only))
NT-proBNP(At baseline, week 14 and week 27 (control arm only))
Soluble ST-2(At baseline, week 14 and week 27 (control arm only))
Galectin-3(At baseline, week 14 and week 27 (control arm only))
Gut microbiome composition(At baseline, week 14 and week 27 (control arm only))
Changes in weight(At baseline, week 14, week 27 (control arm only) and 1 year)
Time in moderate-to-vigorous and sedentary activity(At baseline, week 14, week 27 (control arm only) and 1 year)
Quality of life (child perspective)(At baseline, week 14, week 27 (control arm only) and 1 year)
Quality of life (parent perspective)(At baseline, week 14, week 27 (control arm only) and 1 year)
Quality of life(At baseline, week 14, week 27 (control arm only) and 1 year)
Fatigue-related quality of life(At baseline, week 14, week 27 (control arm only) and 1 year)