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Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease

ConditionsPediatric ALLCongenital Heart DiseaseHeart Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-18
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Participants in this study will be 10-18 year olds, with acquired or congenital heart disease, that are followed by the Stollery Children's Hospital.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Exercise cardiac MRI Assessment

    Diagnostic test

    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

    Diagnostic 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Congenital heart disease2 interventions
Group B: Heart transplant recipient2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

Cardioplumonary Exercise Test

Participants will undergo a cardiopulmonary exercise test using a cycle ergometer to assess VO2peak.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov
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