Clinical trial NCT02161471: Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance
Official title: Haemodynamics and Function of the Atria in Patients With Congenital Heart Defects - Pilot Study by Cardiovascular Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coarctation of the Aorta
Tetralogy of Fallot
Transposition of the Great Arteries
Keywords: Atria, Heart
Function, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Tetralogy, Fallot
Transposition of Great Arteries
Coarctation of the Aorta
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants for the study will be recruited among patients, children and adults, with CHD (groups 1-4) undergoing cardiac magnetic resonance examination for clinical reasons.

1. Patients after repair of coarctation of the aorta
2. Patients after repair of tetralogy of Fallot
3. Patients with transposition of the great arteries after atrial switch (Senning procedure)
4. Patients with transposition of the great arteries after arterial switch operation
5. Children without cardiovascular anomalies undergoing CMR for other clinical reasons not influencing cardiac function (control group)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Right and left atrial volume
timeFrame: Day of CMR (baseline only, no intervention)
Secondary outcomes:
measure: Blood flow across the atrio-ventricular valves
timeFrame: Day of CMR (baseline only, no intervention)
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zürich, Switzerland
state: ZH
Study officials:
affiliation: University Children's Hospital Zürich, Switzerland
name: Emanuela R Valsangiacomo Buechel, Prof.
role: PRINCIPAL_INVESTIGATOR
References: