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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Children's Hospital, Zurich
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT02161471
First received: June 10, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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
Coarctation of the Aorta
Tetralogy of Fallot
Transposition of the Great Arteries

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • Right and left atrial volume [ Time Frame: Day of CMR ] [ Designated as safety issue: No ]
    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:
  • Blood flow across the atrio-ventricular valves [ Time Frame: Day of CMR ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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, 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

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02161471

Locations
Switzerland
University Children's Hospital Zürich, Switzerland Recruiting
Zürich, ZH, Switzerland, 8032
Contact: Barbara EU Burkhardt, MD    +41 44 266 71 11    barbara.burkhardt@kispi.uzh.ch   
Principal Investigator: Emanuela R Valsangiacomo Büchel, Prof.         
Sub-Investigator: Barbara EU Burkhardt, MD         
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Emanuela R Valsangiacomo Buechel, Prof. University Children's Hospital Zürich, Switzerland
  More Information

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT02161471     History of Changes
Other Study ID Numbers: Atrial function in CHD by CMR
Study First Received: June 10, 2014
Last Updated: June 10, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Children's Hospital, Zurich:
Atria, Heart
Function, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Tetralogy, Fallot
Transposition of Great Arteries
Coarctation of the Aorta

Additional relevant MeSH terms:
Aortic Coarctation
Heart Defects, Congenital
Tetralogy of Fallot
Transposition of Great Vessels
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014