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Recruiting NCT06771687

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

No phase Interventional Congenital Heart Disease Truncus Arteriosus Pulmonary Atresia Tetralogy of Fallot

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High intensity interval training.
Who it may be relevant to
Registry conditions: Congenital Heart Disease, Truncus Arteriosus, Pulmonary Atresia, Tetralogy of Fallot. Basic parameters: 12 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral High intensity interval training
    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 outcome measures

  • Peak oxygen consumption [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
Secondary outcome measures (12)
  • Maximum wattage [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Heart rate recovery [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Ventilatory efficiency slope [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Atrial volumes [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Left and right ventricular inflow pattern [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Ventricular size [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Left and right ventricular ejection fraction [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Right ventricular fractional area change [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Tricuspid annular plane systolic excursion (TAPSE) [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Ventricular strain [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Vascular flow [Time frame: At baseline, week 14, week 27 (control arm only) and 1 year]
  • Ventricular size [Time frame: At baseline, week 14 and week 27 (control arm only)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Netherlands · 2 centers
  • Radboudumc — Nijmegen
  • ErasmusMC — Rotterdam

Publications

  • Moerdijk AS, van Genuchten WJ, Duijnhouwer AL, Snoeren MMM, Hirsch A, van den Berg LEM, Boersma E, Kauling RM, van den Bosch AE, Udink Ten Cate FEA, Helbing WA, Bartelds B. Evaluation of high intensity interval training in patients with a right ventricle to pulmonary artery conduit in a randomized controlled trial: Rationale and design of the "Right HIIT" study. Am Heart J. 2026 Sep;299:107477. do PMID 42114665

Identifiers

NCT: NCT06771687 · MEC-2023-0777

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗