Recruiting

Cardiorespiratory Fitness

Sponsor:

University of Alberta

Code:

NCT06325280

Conditions

Pediatric ALL

Congenital Heart Disease

Heart Transplantation

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Exercise cardiac MRI Assessment

Cardiopulmonary Exercise Test

Study Details

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.

Conditions

Pediatric ALL

Congenital Heart Disease

Heart Transplantation

Study ID

NCT06325280

Start date

Jan 20, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Congenital heart disease

Participants aged 10-18 years who have congenital heart disease.

Heart transplant recipient

Participants aged 10-18 years who have recieved a heart transplant.

Interventions

Exercise cardiac MRI Assessment

Participants will undergo a standard cardiac MRI to assess resting ventricular structure and function then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer.

Cardiopulmonary Exercise Test

Cardiopulmonary exercise testing will be performed using a cycle ergometer. Consistent with standard guidelines, workload will progressively increase (10W ramp protocol) such that peak oxygen consumption (VO2peak) is achieved within 8-12 minutes. VO2peak, VO2 at anaerobic threshold, peak power output (PPO), ventilation/carbon dioxide production (VE/VCO2) slope, peak heart rate (HR), and HR recovery at 1- and 3-minutes will be recorded. VO2peak will be converted to age-, weight, and sex-specific norms and a %predicted value.

Primary outcome measure

  • MRI assessment of cardiac structure at rest [ Time Frame: Baseline ]
  • MRI assessment of cardiac function at rest [ Time Frame: Baseline ]
  • Maximal exercise MRI assessment of cardiac structure [ Time Frame: Baseline ]
  • Cardioplumonary Exercise Test [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Rae Foshaug

780-407-7499rae.foshaug@albertahealthservices.ca

Michael Khoury, MD

780-492-0103khoury1@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Rae Foshaug

780-407-7499rae.foshaug@albertahealthservices.ca

Michael Khoury, MD

780-492-0103khoury1@ualberta.ca

Principal Investigator:

Michael Khoury, MD

More Information

Sponsor

University of Alberta

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Pediatric cardiology
  • Exercise cardiac MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-03-16.