Imaging Assessment of Diastolic Function

The Hospital for Sick Children

Status and phase: Unknown; Phase 2

Conditions: Congenital Heart Disease

Treatments: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Echocardiograph

Study type: Interventional

Funder types: Other

Identifiers

NCT01668264

1000017963

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Magnetic Resonance Imaging (MRI)

Experimental group

Description:

Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.

Treatment:

Procedure: Echocardiograph

Procedure: Magnetic Resonance Imaging (MRI)

Echocardiograph

Experimental group

Description:

Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.

Treatment:

Procedure: Echocardiograph

Procedure: Magnetic Resonance Imaging (MRI)