Clinical trial · Observational
Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease
Utilizing Exercise Cardiovascular and Skeletal Magnetic Resonance Imaging to Evaluate Factors Associated With Cardiorespiratory Fitness in Children With Acquired and Congenital Heart Disease
NCT06325280CI-TRIAL-00105564recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Congenital Heart Disease | — | UNRESOLVED | — |
| Heart Transplantation | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiopulmonary Exercise Test | Diagnostic Test | — | UNRESOLVED |
| Exercise cardiac MRI Assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Congenital heart disease
- description
- Participants aged 10-18 years who have congenital heart disease.
- interventionNames
- Diagnostic Test: Exercise cardiac MRI Assessment
- Diagnostic Test: Cardiopulmonary Exercise Test
- label
- Heart transplant recipient
- description
- Participants aged 10-18 years who have recieved a heart transplant.
- interventionNames
- Diagnostic Test: Exercise cardiac MRI Assessment
- Diagnostic Test: Cardiopulmonary Exercise Test
Primary outcomes (4)
- measure
- MRI assessment of cardiac structure at rest
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDKhoury 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. PMID 32716280
- BACKGROUNDSpence 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. PMID 37657493
- BACKGROUNDSpence 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. PMID 37969861