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

NCT06771687 | Recruiting

• 1 other identifier: MEC-2023-0777
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption

  Peak oxygen consumption obtained with CPET

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

Secondary Outcomes (28)

• Maximum wattage

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

• Heart rate recovery

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

• Ventilatory efficiency slope

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

• Atrial volumes

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

• Left and right ventricular inflow pattern

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

Study Arms (2)

Intervention

EXPERIMENTAL

This arm receives the 12-week exercise intervention, with a study visit before and after the intervention.

Behavioral: High intensity interval training

Control

NO INTERVENTION

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Heart Foundation: collaborator
• Radboud University Medical Center: collaborator

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

NOT YET RECRUITING

ErasmusMC

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Truncus Arteriosus, Persistent; Pulmonary Atresia; Tetralogy of Fallot; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortopulmonary Septal Defect; Heart Septal Defects; Vascular Malformations; Heart Valve Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Beatrijs Bartelds, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anouk S Moerdijk, MD

CONTACT

+31107036264; a.moerdijk@erasmusmc.nl

Beatrijs Bartelds, MD, PhD

CONTACT

+31107036264; b.bartelds@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, pediatric cardiologist, associate professor

Model Details: Participants will be randomized into the intervention or control arm. After the control period, participants in the control arm will also receive the intervention.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: January 13, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)