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

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.

Study Overview

• Status: Recruiting
• Conditions: Tetralogy of Fallot; Congenital Heart Disease; Pulmonary Atresia; Truncus Arteriosus
• Intervention / Treatment: Behavioral: High intensity interval training

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anouk S Moerdijk, MD; Phone Number: +31107036264; Email: a.moerdijk@erasmusmc.nl
• Study Contact Backup: Name: Beatrijs Bartelds, MD, PhD; Phone Number: +31107036264; Email: b.bartelds@erasmusmc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Not yet recruiting
      • Radboudumc
      • Contact: Anouk S Moerdijk, MD; Phone Number: +31107036264; Email: a.moerdijk@erasmusmc.nl
      • Principal Investigator: Floris Udink ten Cate, MD, PhD
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Recruiting
      • ErasmusMC
      • Contact: Anouk S Moerdijk, MD; Phone Number: +31107036264; Email: a.moerdijk@erasmusmc.nl
      • Principal Investigator: Beatrijs Bartelds, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This arm receives the 12-week exercise intervention, with a study visit before and after the intervention.	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.
No Intervention: Control; This arm starts with a 12-week control period, after which the participants will also receive the 12-week exercise intervention. Participants will have a study visit before and after the control period and after the intervention. For the primary outcome parameter, only the control period will be used to compare to the intervention. For the secondary outcome parameters (predictors for response), also the intervention period of the control group will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen consumption	Peak oxygen consumption obtained with CPET	At baseline, week 14, week 27 (control arm only) and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum wattage	Maximum wattage obtained with CPET	At baseline, week 14, week 27 (control arm only) and 1 year
Heart rate recovery	Heart rate recovery obtained with CPET	At baseline, week 14, week 27 (control arm only) and 1 year
Ventilatory efficiency slope	Ventilatory efficiency slope obtained with CPET	At baseline, week 14, week 27 (control arm only) and 1 year
Atrial volumes	Atrial volumes obtained with echocardiography	At baseline, week 14, week 27 (control arm only) and 1 year
Left and right ventricular inflow pattern	Left and right ventricular inflow pattern obtained with echocardiography (E and A waves)	At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular size	Ventricular size obtained with echocardiography	At baseline, week 14, week 27 (control arm only) and 1 year
Left and right ventricular ejection fraction	Left ventricular ejection fraction obtained with echocardiography	At baseline, week 14, week 27 (control arm only) and 1 year
Right ventricular fractional area change	Right ventricular fractional area change obtained with echocardiography	At baseline, week 14, week 27 (control arm only) and 1 year
Tricuspid annular plane systolic excursion (TAPSE)	TAPSE obtained with echocardiography	At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular strain	Ventricular strain obtained with echocardiography	At baseline, week 14, week 27 (control arm only) and 1 year
Vascular flow	Vascular flow (aortic valve, RV-PA conduit, mitral and tricuspid valve) obtained with echocardiography	At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular size	Ventricular size obtained with MRI	At baseline, week 14 and week 27 (control arm only)
Right and left ventricular ejection fraction	Right and left ventricular ejection fraction obtained with MRI	At baseline, week 14 and week 27 (control arm only)
Ventricular mass	Ventricular mass obtained with MRI	At baseline, week 14 and week 27 (control arm only)
Vascular flow	Two-dimensional phase-contrast flow in the aorta and main pulmonary artery, obtained with MRI	At baseline, week 14 and week 27 (control arm only)
Ventricular kinetic energy	Ventricular kinetic energy obtained with four-dimensional flow MRI	At baseline, week 14 and week 27 (control arm only)
NT-proBNP	NT-proBNP in blood	At baseline, week 14 and week 27 (control arm only)
GDF-15	GDF-15 in blood	At baseline, week 14 and week 27 (control arm only)
Soluble ST-2	Soluble ST-2 in blood	At baseline, week 14 and week 27 (control arm only)
Galectin-3	Galectin-3 in blood	At baseline, week 14 and week 27 (control arm only)
Gut microbiome composition	Gut microbiome composition analyzed using 16S rRNA sequencing in fecal samples	At baseline, week 14 and week 27 (control arm only)
Changes in weight	Changes in weight (kg) and derivatives such as BMI (weight / height^2, reported in kg/m^2)	At baseline, week 14, week 27 (control arm only) and 1 year
Time in moderate-to-vigorous and sedentary activity	Average time per day and total time (minutes and percentage), measured by accelerometry with the Actigraph waist accelerometer worn for seven days	At baseline, week 14, week 27 (control arm only) and 1 year
Time in moderate-to-vigorous and sedentary activity	Measured using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH) questionnaire	At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life (child perspective)	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)	At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life (parent perspective)	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)	At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life	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)	At baseline, week 14, week 27 (control arm only) and 1 year
Fatigue-related quality of life	Measured by the PedsQL Multidimensional Fatigue Scale for all participants, scale 0-100 (100 being the best outcome)	At baseline, week 14, week 27 (control arm only) and 1 year

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Radboud University Medical Center; Dutch Heart Foundation
• Investigators: Principal Investigator: Beatrijs Bartelds, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Heart Defects, Congenital; High-Intensity Interval Training; Tetralogy of Fallot; Exercise Test; Pulmonary Atresia; Physical Conditioning, Human; Truncus Arteriosus, Persistent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Septal Defects; Vascular Malformations; Aortopulmonary Septal Defect; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Heart Defects, Congenital; Tetralogy of Fallot; Pulmonary Atresia; Truncus Arteriosus, Persistent; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Conditioning, Human; Exercise; High-Intensity Interval Training
• Other Study ID Numbers: MEC-2023-0777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No