Imaging Assessment of Diastolic Function

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01668264
• Other study ID #: 1000017963
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 13, 2012
• Last updated: June 22, 2016

Study information

• Verified date: June 2016
• Source: The Hospital for Sick Children
• Contact: Luc Mertens, MD
• Phone: (416)813-7418
• Email: luc.mertens[@]sickkids.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Echocardiograph

• Magnetic Resonance Imaging (MRI)

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No