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

Sponsor
University Children's Hospital, Zurich (Other)
Overall Status
Unknown status
CT.gov ID
NCT02161471
Collaborator
(none)
50
1
134
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Haemodynamics and Function of the Atria in Patients With Congenital Heart Defects - Pilot Study by Cardiovascular Magnetic Resonance
    Study Start Date :
    Oct 1, 2009
    Anticipated Primary Completion Date :
    Nov 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Children's Hospital Zürich, Switzerland Zürich ZH Switzerland 8032

    Sponsors and Collaborators

    • University Children's Hospital, Zurich

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Children's Hospital, Zurich
    ClinicalTrials.gov Identifier:
    NCT02161471
    Other Study ID Numbers:
    • Atrial function in CHD by CMR
    First Posted:
    Jun 11, 2014
    Last Update Posted:
    Jul 12, 2019
    Last Verified:
    Jul 1, 2019

    Study Results

    No Results Posted as of Jul 12, 2019