Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease

NCT06325280 | Recruiting

• 1 other identifier: Pro00132542
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Pediatric cardiology; Exercise cardiac MRI

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Cardioplumonary Exercise Test

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

  Baseline

Study Arms (2)

Congenital heart disease

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

Diagnostic Test: Exercise cardiac MRI Assessment; Diagnostic Test: Cardiopulmonary Exercise Test

Heart transplant recipient

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

Diagnostic Test: Exercise cardiac MRI Assessment; Diagnostic Test: Cardiopulmonary Exercise Test

Interventions

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.

Congenital heart disease; Heart transplant recipient

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.

Also known as: CPET

Congenital heart disease; Heart transplant recipient

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• year olds followed at the Stollery Children's Hospital
• Heart transplant recipients ≥6 months post-transplant
• Have a moderate-complex congenital heart disease diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 32716280 BACKGROUND

• 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.

  PMID: 37657493 BACKGROUND

• 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.

  PMID: 37969861 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Heart Defects, Congenital

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Michael Khoury, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rae Foshaug

CONTACT

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

Michael Khoury, MD

CONTACT

780-492-0103; khoury1@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 22, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)