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

Haemodynamics and Function of the Atria in Patients With Congenital Heart Defects - Pilot Study 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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zürich, ZH, Switzerland, 8032
      • University Children's Hospital Zurich, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Aortic coarctation; Patients after repair of coarctation of the aorta
Tetralogy of Fallot; Patients after repair of tetralogy of Fallot
TGA atrial switch; Patients with transposition of the great arteries after atrial switch (Senning procedure)
TGA arterial switch; Patients with transposition of the great arteries after arterial switch operation
Normal; Normal controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Emanuela R Valsangiacomo Buechel, Prof., University Children's Hospital Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Congenital Abnormalities; Atria, Heart; Function, Atrial; Heart Defects, Congenital; Cardiovascular Abnormalities; Tetralogy, Fallot; Transposition of Great Arteries; Coarctation of the Aorta
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Tetralogy of Fallot; Transposition of Great Vessels; Aortic Coarctation
• Other Study ID Numbers: Atrial function in CHD by CMR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No