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NCT Number: NCT06771687

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

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.

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Key information

Conditions

Congenital Heart Disease Aortopulmonary Septal Defect Behavior Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Valve Diseases Motor Activity Pulmonary Atresia Tetralogy of Fallot Truncus Arteriosus Truncus Arteriosus, Persistent Vascular Malformations

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc, Nijmegen, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training

Behavioral

A 12-week high intensity interval training program, with 30 minutes of exercise three times a week. The trainings can be completed at home and will be digitally supervised.

Primary outcomes

  1. 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

  1. Maximum wattage

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

    Maximum wattage obtained with CPET

  2. Heart rate recovery

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

    Heart rate recovery obtained with CPET

  3. Ventilatory efficiency slope

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

    Ventilatory efficiency slope obtained with CPET

  4. Atrial volumes

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

    Atrial volumes obtained with echocardiography

  5. Left and right ventricular inflow pattern

    Time frame: 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)

  6. Ventricular size

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

    Ventricular size obtained with echocardiography

  7. Left and right ventricular ejection fraction

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

    Left ventricular ejection fraction obtained with echocardiography

  8. Right ventricular fractional area change

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

    Right ventricular fractional area change obtained with echocardiography

  9. Tricuspid annular plane systolic excursion (TAPSE)

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

    TAPSE obtained with echocardiography

  10. Ventricular strain

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

    Ventricular strain obtained with echocardiography

  11. Vascular flow

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

    Vascular flow (aortic valve, RV-PA conduit, mitral and tricuspid valve) obtained with echocardiography

  12. Ventricular size

    Time frame: At baseline, week 14 and week 27 (control arm only)

    Ventricular size obtained with MRI

  13. Right and left ventricular ejection fraction

    Time frame: At baseline, week 14 and week 27 (control arm only)

    Right and left ventricular ejection fraction obtained with MRI

  14. Ventricular mass

    Time frame: At baseline, week 14 and week 27 (control arm only)

    Ventricular mass obtained with MRI

  15. Vascular flow

    Time frame: 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

  16. Ventricular kinetic energy

    Time frame: At baseline, week 14 and week 27 (control arm only)

    Ventricular kinetic energy obtained with four-dimensional flow MRI

  17. NT-proBNP

    Time frame: At baseline, week 14 and week 27 (control arm only)

    NT-proBNP in blood

  18. GDF-15

    Time frame: At baseline, week 14 and week 27 (control arm only)

    GDF-15 in blood

  19. Soluble ST-2

    Time frame: At baseline, week 14 and week 27 (control arm only)

    Soluble ST-2 in blood

  20. Galectin-3

    Time frame: At baseline, week 14 and week 27 (control arm only)

    Galectin-3 in blood

  21. Gut microbiome composition

    Time frame: At baseline, week 14 and week 27 (control arm only)

    Gut microbiome composition analyzed using 16S rRNA sequencing in fecal samples

  22. Changes in weight

    Time frame: 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)

  23. Time in moderate-to-vigorous and sedentary activity

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

    Average time per day and total time (minutes and percentage), measured by accelerometry with the Actigraph waist accelerometer worn for seven days

  24. Time in moderate-to-vigorous and sedentary activity

    Time frame: 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

  25. Quality of life (child perspective)

    Time frame: 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)

  26. Quality of life (parent perspective)

    Time frame: 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)

  27. Quality of life

    Time frame: 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)

  28. Fatigue-related quality of life

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Anouk S Moerdijk, MD

CONTACT

[email protected]

+31107036264

Beatrijs Bartelds, MD, PhD

CONTACT

[email protected]

+31107036264

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Dutch Heart Foundation
  • Radboud University Medical Center

Registry information

Acronym: Right HIIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 13, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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