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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: University Children's Hospital, Zurich

Current Primary Outcome: Right and left atrial volume [ Time Frame: 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.


Original Primary Outcome: Right and left atrial volume [ Time Frame: Day of CMR ]

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.


Current Secondary Outcome: Blood flow across the atrio-ventricular valves [ Time Frame: 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.


Original Secondary Outcome: Blood flow across the atrio-ventricular valves [ Time Frame: Day of CMR ]

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.


Information By: University Children's Hospital, Zurich

Dates:
Date Received: June 10, 2014
Date Started: October 2009
Date Completion: December 2017
Last Updated: October 12, 2016
Last Verified: October 2016