Clinical trial NCT06771687: High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
Official title: High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Truncus Arteriosus
Pulmonary Atresia
Tetralogy of Fallot
Keywords: Heart Defects, Congenital
Truncus Arteriosus, Persistent
Pulmonary Atresia
Tetralogy of Fallot
Physical Conditioning, Human
High-Intensity Interval Training
Exercise Test
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
name: Radboud University Medical Center
First posted: 2025-01-13
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Peak oxygen consumption
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
Secondary outcomes:
measure: Maximum wattage
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Heart rate recovery
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Ventilatory efficiency slope
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Atrial volumes
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Left and right ventricular inflow pattern
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Ventricular size
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Left and right ventricular ejection fraction
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Right ventricular fractional area change
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Tricuspid annular plane systolic excursion (TAPSE)
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Ventricular strain
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Vascular flow
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Ventricular size
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: Right and left ventricular ejection fraction
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: Ventricular mass
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: Vascular flow
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: Ventricular kinetic energy
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: NT-proBNP
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: GDF-15
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: Soluble ST-2
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: Galectin-3
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: Gut microbiome composition
timeFrame: At baseline, week 14 and week 27 (control arm only)
measure: Changes in weight
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Time in moderate-to-vigorous and sedentary activity
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Time in moderate-to-vigorous and sedentary activity
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Quality of life (child perspective)
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Quality of life (parent perspective)
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Quality of life
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
measure: Fatigue-related quality of life
timeFrame: At baseline, week 14, week 27 (control arm only) and 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Rotterdam
country: Netherlands
facility: ErasmusMC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Beatrijs Bartelds, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: