Congenital Heart DiseaseRight HIITNCT06771687
High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
A study testing High intensity interval training in people with Congenital Heart Disease and Truncus Arteriosus, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Congenital Heart Disease, Truncus Arteriosus, Pulmonary Atresia
- What is being tested?
- High intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 Jan 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Anouk S Moerdijk, MD, +31107036264, a.moerdijk@erasmusmc.nl
Floris Udink ten Cate, MD, PhD
- Recruiting
ErasmusMC
Rotterdam, South Holland, 3015 GD
Anouk S Moerdijk, MD, +31107036264, a.moerdijk@erasmusmc.nl
Beatrijs Bartelds, MD, PhD
About this study
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?
Read more
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.
- Being tested
- High intensity interval training
- Keywords
- Heart Defects, Congenital, Truncus Arteriosus, Persistent, Pulmonary Atresia, Tetralogy of Fallot, Physical Conditioning, Human, High-Intensity Interval Training, Exercise Test
- Medical subject headings
- Heart Defects, Congenital, Truncus Arteriosus, Persistent, Pulmonary Atresia, Tetralogy of Fallot, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm receives the 12-week exercise intervention, with a study visit before and after the intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption
Peak oxygen consumption obtained with CPET
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Secondary outcomes (28)
Maximum wattage
Maximum wattage obtained with CPET
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Heart rate recovery
Heart rate recovery obtained with CPET
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Ventilatory efficiency slope
Ventilatory efficiency slope obtained with CPET
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Atrial volumes
Atrial volumes obtained with echocardiography
Measured: 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)
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular size
Ventricular size obtained with echocardiography
Measured: 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
Measured: 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
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Tricuspid annular plane systolic excursion (TAPSE)
TAPSE obtained with echocardiography
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular strain
Ventricular strain obtained with echocardiography
Measured: 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
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Ventricular size
Ventricular size obtained with MRI
Measured: 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
Measured: At baseline, week 14 and week 27 (control arm only)
Ventricular mass
Ventricular mass obtained with MRI
Measured: 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
Measured: At baseline, week 14 and week 27 (control arm only)
Ventricular kinetic energy
Ventricular kinetic energy obtained with four-dimensional flow MRI
Measured: At baseline, week 14 and week 27 (control arm only)
NT-proBNP
NT-proBNP in blood
Measured: At baseline, week 14 and week 27 (control arm only)
GDF-15
GDF-15 in blood
Measured: At baseline, week 14 and week 27 (control arm only)
Soluble ST-2
Soluble ST-2 in blood
Measured: At baseline, week 14 and week 27 (control arm only)
Galectin-3
Galectin-3 in blood
Measured: At baseline, week 14 and week 27 (control arm only)
Gut microbiome composition
Gut microbiome composition analyzed using 16S rRNA sequencing in fecal samples
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At baseline, week 14, week 27 (control arm only) and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start16 Jan 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized into the intervention or control arm. After the control period, participants in the control arm will also receive the intervention.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation, Radboud University Medical Center
- Responsible party
- Principal investigator, Beatrijs Bartelds, Erasmus Medical Center
- Investigators
- Beatrijs Bartelds, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771687
- Sponsor's protocol ID
- MEC-2023-0777
- Acronym
- Right HIIT
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1016/j.ahj.2026.107477. Epub 2026 May 21.
PubMed 42114665
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
- ClinicalTrials.gov ID
- NCT06771687
- Acronym / sponsor ID
- Right HIIT / MEC-2023-0777
- Keywords
- Heart Defects, Congenital, Truncus Arteriosus, Persistent, Pulmonary Atresia, Tetralogy of Fallot, Physical Conditioning, Human, High-Intensity Interval Training, Exercise Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation, Radboud University Medical Center
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into the intervention or control arm. After the control period, participants in the control arm will also receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: High intensity interval trainingThis arm receives the 12-week exercise intervention, with a study visit before and after the intervention. |
| 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. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity interval trainingA 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. | Behavioural | Intervention |
Primary outcome
Peak oxygen consumption
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Peak oxygen consumption obtained with CPET
28 secondary outcomes
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)
Right and left ventricular ejection fraction
Time frame: At baseline, week 14 and week 27 (control arm only)
Ventricular mass
Time frame: At baseline, week 14 and week 27 (control arm only)
Vascular flow
Time frame: At baseline, week 14 and week 27 (control arm only)
Ventricular kinetic energy
Time frame: At baseline, week 14 and week 27 (control arm only)
NT-proBNP
Time frame: At baseline, week 14 and week 27 (control arm only)
GDF-15
Time frame: At baseline, week 14 and week 27 (control arm only)
Soluble ST-2
Time frame: At baseline, week 14 and week 27 (control arm only)
Galectin-3
Time frame: At baseline, week 14 and week 27 (control arm only)
Gut microbiome composition
Time frame: At baseline, week 14 and week 27 (control arm only)
Changes in weight
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Time in moderate-to-vigorous and sedentary activity
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Time in moderate-to-vigorous and sedentary activity
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life (child perspective)
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life (parent perspective)
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Quality of life
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Fatigue-related quality of life
Time frame: At baseline, week 14, week 27 (control arm only) and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 42114665Moerdijk 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. doi: 10.1016/j.ahj.2026.107477. Epub 2026 May 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatrijs Bartelds, MD, PhD principal investigator
Erasmus Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training in people with Congenital Heart Disease and Truncus Arteriosus, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anouk S Moerdijk, MD (+31107036264, a.moerdijk@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (time frame: At baseline, week 14, week 27 (control arm only) and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06771687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.