Congenital Heart Disease Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
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. — View Citation
Spence 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. — View Citation
Spence 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline | |
Primary | 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. | Baseline | |
Primary | 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. | Baseline | |
Primary | Cardioplumonary Exercise Test | Participants will undergo a cardiopulmonary exercise test using a cycle ergometer to assess VO2peak. | Baseline |
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