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

Not Applicable

Recruiting

• Conditions: Congenital Heart Disease; Truncus Arteriosus; Pulmonary Atresia; Tetralogy of Fallot

• Registration Number: NCT06771687
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-16
• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2027-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption	At baseline, week 14, week 27 (control arm only) and 1 year	Peak oxygen consumption obtained with CPET

Secondary Outcome Measures

Name	Time	Method
GDF-15	At baseline, week 14 and week 27 (control arm only)	GDF-15 in blood
Ventricular strain	At baseline, week 14, week 27 (control arm only) and 1 year	Ventricular strain obtained with echocardiography
Tricuspid annular plane systolic excursion (TAPSE)	At baseline, week 14, week 27 (control arm only) and 1 year	TAPSE obtained with echocardiography
Left and right ventricular ejection fraction	At baseline, week 14, week 27 (control arm only) and 1 year	Left ventricular ejection fraction obtained with echocardiography
Right ventricular fractional area change	At baseline, week 14, week 27 (control arm only) and 1 year	Right ventricular fractional area change obtained with echocardiography
Maximum wattage	At baseline, week 14, week 27 (control arm only) and 1 year	Maximum wattage obtained with CPET
Heart rate recovery	At baseline, week 14, week 27 (control arm only) and 1 year	Heart rate recovery obtained with CPET
Ventilatory efficiency slope	At baseline, week 14, week 27 (control arm only) and 1 year	Ventilatory efficiency slope obtained with CPET
Atrial volumes	At baseline, week 14, week 27 (control arm only) and 1 year	Atrial volumes obtained with echocardiography
Left and right ventricular inflow pattern	At baseline, week 14, week 27 (control arm only) and 1 year	Left and right ventricular inflow pattern obtained with echocardiography (E and A waves)
Ventricular size	At baseline, week 14 and week 27 (control arm only)	Ventricular size obtained with MRI
Vascular flow	At baseline, week 14 and week 27 (control arm only)	Two-dimensional phase-contrast flow in the aorta and main pulmonary artery, obtained with MRI
Right and left ventricular ejection fraction	At baseline, week 14 and week 27 (control arm only)	Right and left ventricular ejection fraction obtained with MRI
Ventricular mass	At baseline, week 14 and week 27 (control arm only)	Ventricular mass obtained with MRI
Ventricular kinetic energy	At baseline, week 14 and week 27 (control arm only)	Ventricular kinetic energy obtained with four-dimensional flow MRI
NT-proBNP	At baseline, week 14 and week 27 (control arm only)	NT-proBNP in blood
Soluble ST-2	At baseline, week 14 and week 27 (control arm only)	Soluble ST-2 in blood
Galectin-3	At baseline, week 14 and week 27 (control arm only)	Galectin-3 in blood
Gut microbiome composition	At baseline, week 14 and week 27 (control arm only)	Gut microbiome composition analyzed using 16S rRNA sequencing in fecal samples
Changes in weight	At baseline, week 14, week 27 (control arm only) and 1 year	Changes in weight (kg) and derivatives such as BMI (weight / height\^2, reported in kg/m\^2)
Time in moderate-to-vigorous and sedentary activity	At baseline, week 14, week 27 (control arm only) and 1 year	Measured using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH) questionnaire
Quality of life (child perspective)	At baseline, week 14, week 27 (control arm only) and 1 year	Measured by Child Health Questionnaire (CHQ) Child Form (CF) (CHQ-CF45) for participants aged under 18 years, scale 0-100 (100 being the best outcome)
Quality of life (parent perspective)	At baseline, week 14, week 27 (control arm only) and 1 year	Measured by Child Health Questionnaire (CHQ) Parent Form (PF) (CHQ-PF28) for participants aged under 18 years, scale 0-100 (100 being the best outcome)
Quality of life	At baseline, week 14, week 27 (control arm only) and 1 year	Measured by the 36-Item Short Form Health Survey (SF-36) questionnaire for participants aged over 18 years, scale 0-100 (100 being the best outcome)
Fatigue-related quality of life	At baseline, week 14, week 27 (control arm only) and 1 year	Measured by the PedsQL Multidimensional Fatigue Scale for all participants, scale 0-100 (100 being the best outcome)

Trial Locations

Locations (2)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands

ErasmusMC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands