Imaging Assessment of Diastolic Function

Study Overview
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Brief Summary
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Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. The main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. Overall there is a lack of studies correlating different echocardiographic and MRI parameters of heart function in pediatric populations with congenital or acquired heart diseases. This study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. This study hypothesizes the following: Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo might be the best method for follow-up. Cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. This is related to changes in cardiac mechanics influencing diastolic parameters. Especially the influence on twisting and untwisting will be studied. Regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact

Official Title
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Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Procedure: Echocardiograph
* Procedure: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with tetralogy of Fallot post repair, transposition of great arteries after arterial switch operation, aortic valvulopathy (aortic stenosis and aortic regurgitation), coarctation of the aorta and cardiomyopathy, who are planned to undergo a cardiac MRI will be eligible. Informed consent Exclusion Criteria: Lack of informed consent Need for general anesthesia Similar contraindications as for a clinical MRI study apply.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Resonance Imaging (MRI)<br>Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI. | Procedure: Echocardiograph<br> <br> Procedure: Magnetic Resonance Imaging (MRI)<br> <br> |
| Experimental: Echocardiograph<br>Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI. | Procedure: Echocardiograph<br> <br> Procedure: Magnetic Resonance Imaging (MRI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Volumes | Measure right and left atrial volumes by 2D and 3D echo and correlate the different echocardiographic measurements with MRI. This will allow identifying the most accurate measurement which can be used in clinical practice. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Ventricular Volumes | Assess ventricular volumes and mass and calculate mass/volume ratio. Study the effect of ventricular remodeling on myocardial mechanics especially twisting and untwisting. Relate these changes to evaluation of diastolic function. | Day 1 | 
| Myocardial Scarring | Assess the presence of myocardial scarring in specific populations with congenital heart disease and correlate the findings with regional and global systolic and diastolic dysfunction. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Congenital Heart Disease, Diastolic Function, Echocardiograph, MRI