Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance

Tetralogy of Fallot Clinical Trial

Official title:

Haemodynamics and Function of the Atria in Patients With Congenital Heart Defects - Pilot Study by Cardiovascular Magnetic Resonance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02161471
• Other study ID #: Atrial function in CHD by CMR
• Status: Active, not recruiting
• Start date: October 2009
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether patients with repaired congenital heart disease show differences in size or function of their heart atria compared to normal controls and depending on the nature of their heart disease.

Description:

Atrial function is important for good ventricular filling and function. In patients with impaired cardiac function, atrial contraction is even more important. So far, the size and function of the atria have been assessed two-dimensionally by angiography and by echocardiography. However, these do not allow exact characterization of the volumetric changes of the atria during the cardiac cycle. Recently, cardiac magnetic resonance (CMR) has been used to assess size and function of the left atrium in adults. Little data are available about function and volume of the atria in children and the role of the atria in congenital heart disease (CHD).

The study will recruit patients with CHD (n=40) and normal controls (n=10). The patient group will be composed by patients suffering from the following conditions: coarctation of the aorta (n=10), tetralogy of Fallot (n=10), transposition of the great arteries after atrial switch (Senning procedure) (n=10), transposition of the great arteries after arterial switch operation (n=10).

The study consists of measurements of sizes and function of the right and the left atrium, respectively, by examining three-dimensional volume changes across the heart cycle, and of phase contrast measurements of blood flow across the valves of the heart.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Ability to perform repetitive breath holds of 10-15 seconds each

• Written informed consent of the patients or their legal guardians

Exclusion Criteria:

• Patients requiring general anaesthesia

• Residual cardiac findings which might potentially influence the size and function of the atria

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of the Aorta
• Tetralogy of Fallot
• Transposition of Great Vessels
• Transposition of the Great Arteries

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zürich, Switzerland	Zürich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right and left atrial volume	Measurement of maximal volume (at end of systole), volume before atrial contraction (in late diastole), and minimal volume (at end of diastole) of both atria.	Day of CMR (baseline only, no intervention)
Secondary	Blood flow across the atrio-ventricular valves	Phase contrast measurement of blood flow across the atrio-ventricular and the ventriculo-arterial valves, respectively, to serve as an internal validation of total atrial emptying volumes, as well as to contribute maximum early and late diastolic velocities.	Day of CMR (baseline only, no intervention)