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Completed

NCT Number: NCT02161471

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

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.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zürich, Switzerland

Zurich, Canton of Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 11, 2014
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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