Pediatric ALLNCT06325280
Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease
An observational study of Pediatric ALL and Congenital Heart Disease, run by University of Alberta at 1 site in Canada.
Trial summary
There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pediatric ALL, Congenital Heart Disease, Heart Transplantation
- What is being tested?
- Exercise cardiac MRI Assessment and Cardiopulmonary Exercise Test
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2025to 31 Dec 2027
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants in this study will be 10-18 year olds, with acquired or congenital heart disease, that are followed by the Stollery Children's Hospital.
Who may be able to join
- 10 - 18 year olds followed at the Stollery Children's Hospital
- Heart transplant recipients ≥6 months post-transplant
- Have a moderate-complex congenital heart disease diagnosis
Who cannot join
- Non-English speaking
- Exercise restricted by the patient's clinical cardiologist
- Clinical antibody- or cellular-mediated rejection within 3-months of the assessment or during the study period (for HTRs)
- Previous involvement in a CR or exercise intervention program
- Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (<20 mmHg) or a systolic BP >200 mmHg, or symptoms of chest pain or syncope
- Resting arterial saturation <85% or oxygen requirements
Show all 15Show fewer
- Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram
- History of chest pain on exertion; unrepaired/unpalliated CHD
- Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block or history of (Mobitz II or worse))
- New York Heart Association class II or worse symptoms
- Active medical inter-current illness limiting ability to participate
- Cognitive impairment limiting the communication needed for the exercise MRI
- Research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing
- Extracardiac or congenital abnormality limiting the participant's functional ability to exercise
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2B7
Rae Foshaug, 780-407-7499, rae.foshaug@albertahealthservices.ca
Michael Khoury, MD, 780-492-0103, khoury1@ualberta.ca
About this study
Official title: Utilizing Exercise Cardiovascular and Skeletal Magnetic Resonance Imaging to Evaluate Factors Associated With Cardiorespiratory Fitness in Children With Acquired and Congenital Heart Disease
There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function.
Read the detailed description
Exercise cardiac MRI's are the non-invasive gold standard for assessing biventricular function during exercise. While exercise MRI has not been previously studied in pediatric HTRs, it has been effectively utilized in children with single ventricle congenital heart disease. The purpose of this study is to fully understand the cardiac adaptations induced by exercise training.
Primary objective: Evaluate the association between exercise MRI cardiac and skeletal muscle measures and cardiorespiratory fitness in pediatric acquired (HTRx) and CHD participants.
Hypothesis: Cardiac adaptations to exercise and skeletal muscle functioning will be positively associated with measured CRF in CHD patients and those post-transplant.
Secondary objective: Evaluate changes in exercise MRI measures of cardiac and skeletal muscle function following a 12-week high-intensity interval training (HIIT) exercise protocol in children with acquired and congenital heart disease.
Hypothesis: a 12-week HIIT intervention will result in improvements in cardiac and skeletal muscle responses to exercise.
This will be a single-center, prospective observational study.
Participants will include 10-18 year old pediatric heart transplant recipients (HTR) and congenital heart disease (CHD) patients followed at the Stollery Children's Hospital.
Participants will undergo cardiopulmonary exercise testing (CPET) using a cycle ergometer and standardized protocols. On a separate day (within 2 weeks of the testing), participants will return and undergo a standard cardiac MRI to assess resting ventricular structure and function. They will then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer.
Participants and their parent will also be asked to complete questionnaires to determine their feelings towards exercise and physical activity.
As this will be a single-center study. The analysis will be largely exploratory and the sample size will be determined based on the available patient population. Based on a review of potentially eligible participants at our center, the investigators anticipate recruiting 10 participants post-HTR and 10 CHD participants to evaluate the primary objective. As the secondary objective (changes in cardiac and skeletal muscle MRI measures) requires repeated assessments and involvement in the MedBIKE™ HIIT trial, recruitment to address this objective may be lessened; the investigators thus anticipate recruiting ~6 participants post-transplant and 6 participants with CHD. The statistical analysis will be carried out in collaboration with the Women and Children's Health Research Institute (WCHRI) biostatistics team (accounted for in budget). Differences in MRI and CPET measures among participants, and changes in the measures (Objective 2) will be evaluated by independent t-tests or Mann-Whitney tests for continuous variables and chi-square or Fisher's exact tests for categorical variables. Pearson correlations will be used to evaluate associations between VO2peak (and other CPET measures of CRF) and measures of cardiac function and output and peripheral muscle oxygen extraction.
- Being tested
- Exercise cardiac MRI Assessment, Cardiopulmonary Exercise Test
- Keywords
- Pediatric cardiology, Exercise cardiac MRI
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise cardiac MRI AssessmentDiagnostic test
Participants will undergo a standard cardiac MRI to assess resting ventricular structure and function then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer.
Cardiopulmonary Exercise TestDiagnostic test
Also called CPET
Cardiopulmonary exercise testing will be performed using a cycle ergometer. Consistent with standard guidelines, workload will progressively increase (10W ramp protocol) such that peak oxygen consumption (VO2peak) is achieved within 8-12 minutes. VO2peak, VO2 at anaerobic threshold, peak power output (PPO), ventilation/carbon dioxide production (VE/VCO2) slope, peak heart rate (HR), and HR recovery at 1- and 3-minutes will be recorded. VO2peak will be converted to age-, weight, and sex-specific norms and a %predicted value.
| Study group | Role | What they receive |
|---|---|---|
| Congenital heart disease | Participants aged 10-18 years who have congenital heart disease. Receives: Diagnostic Test: Exercise cardiac MRI Assessment; Diagnostic Test: Cardiopulmonary Exercise Test | |
| Heart transplant recipient | Participants aged 10-18 years who have recieved a heart transplant. Receives: Diagnostic Test: Exercise cardiac MRI Assessment; Diagnostic Test: Cardiopulmonary Exercise Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI assessment of cardiac structure at rest
Participants will undergo a standard cardiac MRI using a Siemens MAGNETOM Prisma 3.0T CMR (Siemens Healthineers, Erlangen, Germany) for the assessment of resting ventricular structure.
Measured: Baseline
MRI assessment of cardiac function at rest
Participants will undergo a standard cardiac MRI using a Siemens MAGNETOM Prisma 3.0T CMR (Siemens Healthineers, Erlangen, Germany) for the assessment of resting ventricular function.
Measured: Baseline
Maximal exercise MRI assessment of cardiac structure
Participants will undergo an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer (Cardio Step Module, Ergospect) to assess cardiac output.
Measured: Baseline
Cardioplumonary Exercise Test
Participants will undergo a cardiopulmonary exercise test using a cycle ergometer to assess VO2peak.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start20 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Khoury, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325280
- Sponsor's protocol ID
- Pro00132542
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. All data will be de-identified prior to analysis and published.
Publications
Khoury M, Phillips DB, Wood PW, Mott WR, Stickland MK, Boulanger P, Rempel GR, Conway J, Mackie AS, Khoo NS. Cardiac rehabilitation in the paediatric Fontan population: development of a home-based high-intensity interval training programme. Cardiol Young. 2020 Oct;30(10):1409-1416. doi: 10.1017/S1047951120002097. Epub 2020 Jul 27.
PubMed 32716280Spence C, Khoo N, Mackie A, Conway J, Rowland S, Foshaug R, Boulanger P, Spence JC, Stickland MK, Khoury M. Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. Can J Cardiol. 2023 Nov;39(11S):S346-S358. doi: 10.1016/j.cjca.2023.08.015. Epub 2023 Aug 30.
PubMed 37657493Spence CM, Foshaug R, Rowland S, Krysler A, Conway J, Urschel S, West L, Stickland M, Boulanger P, Spence JC, Khoury M. Evaluating a Telemedicine Video Game-Linked High-Intensity Interval Training Exercise Programme in Paediatric Heart Transplant Recipients. CJC Pediatr Congenit Heart Dis. 2023 Apr 11;2(4):198-205. doi: 10.1016/j.cjcpc.2023.04.001. eCollection 2023 Aug.
PubMed 37969861
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Exercise Cardiovascular and Skeletal Magnetic Resonance Imaging to Evaluate Factors Associated With Cardiorespiratory Fitness in Children With Acquired and Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06325280
- Acronym / sponsor ID
- Pro00132542
- Keywords
- Pediatric cardiology, Exercise cardiac MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Mar 2024 (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.
There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function.
Detailed description
Exercise cardiac MRI's are the non-invasive gold standard for assessing biventricular function during exercise. While exercise MRI has not been previously studied in pediatric HTRs, it has been effectively utilized in children with single ventricle congenital heart disease. The purpose of this study is to fully understand the cardiac adaptations induced by exercise training.
Primary objective: Evaluate the association between exercise MRI cardiac and skeletal muscle measures and cardiorespiratory fitness in pediatric acquired (HTRx) and CHD participants.
Hypothesis: Cardiac adaptations to exercise and skeletal muscle functioning will be positively associated with measured CRF in CHD patients and those post-transplant.
Secondary objective: Evaluate changes in exercise MRI measures of cardiac and skeletal muscle function following a 12-week high-intensity interval training (HIIT) exercise protocol in children with acquired and congenital heart disease.
Hypothesis: a 12-week HIIT intervention will result in improvements in cardiac and skeletal muscle responses to exercise.
This will be a single-center, prospective observational study.
Participants will include 10-18 year old pediatric heart transplant recipients (HTR) and congenital heart disease (CHD) patients followed at the Stollery Children's Hospital.
Participants will undergo cardiopulmonary exercise testing (CPET) using a cycle ergometer and standardized protocols. On a separate day (within 2 weeks of the testing), participants will return and undergo a standard cardiac MRI to assess resting ventricular structure and function. They will then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer.
Participants and their parent will also be asked to complete questionnaires to determine their feelings towards exercise and physical activity.
As this will be a single-center study. The analysis will be largely exploratory and the sample size will be determined based on the available patient population. Based on a review of potentially eligible participants at our center, the investigators anticipate recruiting 10 participants post-HTR and 10 CHD participants to evaluate the primary objective. As the secondary objective (changes in cardiac and skeletal muscle MRI measures) requires repeated assessments and involvement in the MedBIKE™ HIIT trial, recruitment to address this objective may be lessened; the investigators thus anticipate recruiting ~6 participants post-transplant and 6 participants with CHD. The statistical analysis will be carried out in collaboration with the Women and Children's Health Research Institute (WCHRI) biostatistics team (accounted for in budget). Differences in MRI and CPET measures among participants, and changes in the measures (Objective 2) will be evaluated by independent t-tests or Mann-Whitney tests for continuous variables and chi-square or Fisher's exact tests for categorical variables. Pearson correlations will be used to evaluate associations between VO2peak (and other CPET measures of CRF) and measures of cardiac function and output and peripheral muscle oxygen extraction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital heart disease | – | Diagnostic Test: Exercise cardiac MRI Assessment, Diagnostic Test: Cardiopulmonary Exercise TestParticipants aged 10-18 years who have congenital heart disease. |
| Heart transplant recipient | – | Diagnostic Test: Exercise cardiac MRI Assessment, Diagnostic Test: Cardiopulmonary Exercise TestParticipants aged 10-18 years who have recieved a heart transplant. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants in this study will be 10-18 year olds, with acquired or congenital heart disease, that are followed by the Stollery Children's Hospital.
Key inclusion criteria (3 listed)
- 10 - 18 year olds followed at the Stollery Children's Hospital
- Heart transplant recipients ≥6 months post-transplant
- Have a moderate-complex congenital heart disease diagnosis
Key exclusion criteria (15 listed)
- Non-English speaking
- Exercise restricted by the patient's clinical cardiologist
- Clinical antibody- or cellular-mediated rejection within 3-months of the assessment or during the study period (for HTRs)
- Previous involvement in a CR or exercise intervention program
- Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (<20 mmHg) or a systolic BP >200 mmHg, or symptoms of chest pain or syncope
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 |
|---|---|---|
| Exercise cardiac MRI AssessmentParticipants will undergo a standard cardiac MRI to assess resting ventricular structure and function then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer. | Diagnostic test | Congenital heart disease, Heart transplant recipient |
| Cardiopulmonary Exercise TestAlso: CPETCardiopulmonary exercise testing will be performed using a cycle ergometer. Consistent with standard guidelines, workload will progressively increase (10W ramp protocol) such that peak oxygen consumption (VO2peak) is achieved within 8-12 minutes. VO2peak, VO2 at anaerobic threshold, peak power output (PPO), ventilation/carbon dioxide production (VE/VCO2) slope, peak heart rate (HR), and HR recovery at 1- and 3-minutes will be recorded. VO2peak will be converted to age-, weight, and sex-specific norms and a %predicted value. | Diagnostic test | Congenital heart disease, Heart transplant recipient |
Primary outcome
MRI assessment of cardiac structure at rest
Time frame: Baseline
Participants will undergo a standard cardiac MRI using a Siemens MAGNETOM Prisma 3.0T CMR (Siemens Healthineers, Erlangen, Germany) for the assessment of resting ventricular structure.
MRI assessment of cardiac function at rest
Time frame: Baseline
Participants will undergo a standard cardiac MRI using a Siemens MAGNETOM Prisma 3.0T CMR (Siemens Healthineers, Erlangen, Germany) for the assessment of resting ventricular function.
Maximal exercise MRI assessment of cardiac structure
Time frame: Baseline
Participants will undergo an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer (Cardio Step Module, Ergospect) to assess cardiac output.
Cardioplumonary Exercise Test
Time frame: Baseline
Participants will undergo a cardiopulmonary exercise test using a cycle ergometer to assess VO2peak.
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 16 Mar 2026.
- Background: PubMed 32716280Khoury M, Phillips DB, Wood PW, Mott WR, Stickland MK, Boulanger P, Rempel GR, Conway J, Mackie AS, Khoo NS. Cardiac rehabilitation in the paediatric Fontan population: development of a home-based high-intensity interval training programme. Cardiol Young. 2020 Oct;30(10):1409-1416. doi: 10.1017/S1047951120002097. Epub 2020 Jul 27.
- Background: PubMed 37657493Spence C, Khoo N, Mackie A, Conway J, Rowland S, Foshaug R, Boulanger P, Spence JC, Stickland MK, Khoury M. Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. Can J Cardiol. 2023 Nov;39(11S):S346-S358. doi: 10.1016/j.cjca.2023.08.015. Epub 2023 Aug 30.
- Background: PubMed 37969861Spence CM, Foshaug R, Rowland S, Krysler A, Conway J, Urschel S, West L, Stickland M, Boulanger P, Spence JC, Khoury M. Evaluating a Telemedicine Video Game-Linked High-Intensity Interval Training Exercise Programme in Paediatric Heart Transplant Recipients. CJC Pediatr Congenit Heart Dis. 2023 Apr 11;2(4):198-205. doi: 10.1016/j.cjcpc.2023.04.001. eCollection 2023 Aug.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. All data will be de-identified prior to analysis and published.
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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.
Michael Khoury, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL and Congenital Heart Disease, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 15 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Rae Foshaug (780-407-7499, rae.foshaug@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI assessment of cardiac structure at rest (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT06325280, which also lists 3 linked publications.
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 16 Mar 2026.