NCT06325280 Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease
| NCT ID | NCT06325280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Pediatric ALL |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-01-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Michael Khoury, MD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT06325280 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Pediatric ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06325280 currently recruiting?
Yes, NCT06325280 is actively recruiting participants. Contact the research team at rae.foshaug@albertahealthservices.ca for enrollment information.
Where is the NCT06325280 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT06325280 clinical trial?
NCT06325280 is sponsored by University of Alberta. The principal investigator is Michael Khoury, MD at University of Alberta. The trial plans to enroll 20 participants.