Evaluating heart and muscle function during exercise 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
This study is testing how well the hearts and muscles of kids with heart disease work during exercise to see if a special workout program can help them get stronger and healthier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT06325280 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how heart and skeletal muscles work together during exercise in pediatric patients with congenital heart disease and those who have undergone heart transplantation. Using exercise cardiac MRI, the study will evaluate blood flow, oxygenation, and cardiac function in participants aged 10-18 years. The primary objective is to explore the relationship between exercise MRI measures and cardiorespiratory fitness, while a secondary objective will assess the effects of a 12-week high-intensity interval training program on cardiac and skeletal muscle responses. The study will take place at the Stollery Children's Hospital in Edmonton, Alberta.
Who should consider this trial
Good fit: Ideal candidates are 10-18 year old pediatric heart transplant recipients or those with moderate-complex congenital heart disease.
Not a fit: Patients who are non-English speaking, have recent clinical rejection episodes, or significant exercise restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise protocols and rehabilitation strategies for children with heart disease, enhancing their overall fitness and quality of life.
How similar studies have performed: While exercise MRI has been effectively used in children with single ventricle congenital heart disease, this specific application in pediatric heart transplant recipients is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Michael Khoury, MD — University of Alberta
- Study coordinator: Rae Foshaug
- Email: rae.foshaug@albertahealthservices.ca
- Phone: 780-407-7499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.