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

Completed

• Conditions: Transposition of the Great Arteries; Coarctation of the Aorta; Tetralogy of Fallot

• Registration Number: NCT02161471
• Lead Sponsor: University Children's Hospital, Zurich

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-06-16
• Primary Completion: 2009-11-24
• Study Completion: 2009-11-24
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Right and left atrial volume	Day of CMR (baseline only, no intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Blood flow across the atrio-ventricular valves	Day of CMR (baseline only, no intervention)	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.

Trial Locations

Locations (1)

University Children's Hospital Zürich, Switzerland; 🇨🇭 Zürich, ZH, Switzerland