Evaluating heart and muscle function during exercise in children with heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.