Exercise MRI for Congenital Heart Disease

Overseen By Michael Khoury, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Non-English, Arrhythmias, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how the heart and muscles work together during exercise in children with heart conditions. Researchers will use MRI scans to observe blood flow and muscle function during physical activity. Children aged 10-18 who have had a heart transplant or have congenital heart disease and receive care at Stollery Children's Hospital may be suitable candidates.

As an unphased trial, this study offers participants a unique opportunity to contribute to valuable research that could enhance future care for children with heart conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this MRI technique is safe for pediatric patients with heart disease?

Research has shown that Exercise MRI, which uses magnetic resonance imaging during exercise, is generally safe for assessing heart function. Studies have found that this method can be performed safely and reliably in various situations. For example, one study demonstrated that using a type of MRI called stress perfusion CMR is safe and provides valuable information about heart function.

Although these studies examined various heart conditions, they suggest that Exercise MRI itself does not cause significant harm or side effects. This method gathers important information about blood flow and heart health without requiring surgery. It is a well-tolerated option for assessing heart function, even in children with heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses exercise MRI to assess cardiorespiratory fitness in children with heart disease, offering a non-invasive way to gather detailed information about heart function. Unlike standard tests like echocardiograms or stress tests, exercise MRI can provide comprehensive insights into how well the heart and lungs work together during physical activity. This could lead to better-tailored treatments and management strategies for young patients with heart disease, improving their quality of life and long-term outcomes.

What evidence suggests that Exercise MRI is effective for evaluating heart and skeletal muscle function in pediatric heart disease?

Research has shown that exercise benefits children with heart conditions, including those who have had heart transplants or were born with heart problems. Exercise can enhance their bodies' oxygen use and strengthen muscles. In this trial, participants will be divided into two groups: those who have received heart transplants and those with congenital heart disease. For children with congenital heart disease, exercise tests can identify those who might face more health issues. These findings suggest that exercise MRI, used to assess heart and muscle function during exercise, could offer crucial information for managing their heart health. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Khoury, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 10 and 18 years old and am a patient at Stollery Children's Hospital.

I received a heart transplant more than 6 months ago.

I have been diagnosed with a moderate to complex heart condition from birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo cardiopulmonary exercise testing and resting cardiac MRI

1 day

1 visit (in-person)

Exercise MRI Assessment

Participants complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer

1 day

1 visit (in-person)

12-week HIIT Exercise Protocol

Participants undergo a 12-week high-intensity interval training exercise protocol

12 weeks

Follow-up

Participants are monitored for changes in cardiac and skeletal muscle MRI measures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise MRI

How Is the Trial Designed?

Group I: Heart transplant recipient Experimental Treatment 2 Interventions

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

Group II: Congenital heart disease Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8603635/

Exercise training in heart transplantation - PubMed Central - NIH Heart transplant recipients present 20% lower peak exercise end-diastolic volume and stroke volume than healthy people[21,22]. This is another significant ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1097664724011657

Multiparametric cardiovascular magnetic resonance is ... Cardiac death occurred in 2% (2/113), re-transplantation in 4% (4/113), and cardiac hospitalization in 22% (25/113). Non-cardiac death did not occur. Using ...

3. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.112.000103

Prognostic Value of Exercise Testing During Heart ... Exercise testing during HT evaluation in children with biventricular circulation identified those at higher risk of death or deterioration in this small study.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824913

Patient-Reported Outcomes Among Adults With Congenital ... This cohort study reports the initial findings of patient-reported outcomes for adult patients with congenital heart disease from the first ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/nbk84851/

Effects of exercise training in heart transplant recipients - NCBI CONCLUSION: Exercise training is recommended for heart transplant recipients to improve peak VO(2) and muscle strength despite the small number of trials ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11783449/

Multiparametric cardiovascular magnetic resonance is ... The mean follow-up time was 2.3 ± 1.9 years, median 1.4 years (interquartile range 0.9–3.0 years). The composite outcome occurred in 22% (25/113). Cardiac death ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.057006

Cardiovascular Magnetic Resonance for Rejection ... We tested the hypothesis that CMR-based monitoring for cardiac allograft rejection was feasible compared with EMB-based monitoring in the first ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1097664723004763

Multi-parametric cardiovascular magnetic resonance with ... Regadenoson stress perfusion CMR could be safely and reliably performed. Increasing T2 values were associated with worsening left ventricular function.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8423146/

Cardiovascular Magnetic Resonance Feature Tracking Global ... In a large cohort of heart transplant recipients, CMR-FT GLS was independently associated with the long-term risk of death or MACE.

10. jhltonline.org jhltonline.org/article/S1053-2498(23)02175-7/abstract

Cardiac magnetic resonance assessment of acute rejection ... Cardiac magnetic resonance assessment of acute rejection and cardiac allograft vasculopathy in pediatric heart transplant. Sandra Kikano, MD.