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

NCT ID: NCT02161471

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-16

Study Completion Date

2009-11-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tetralogy of Fallot

Patients after repair of tetralogy of Fallot

No interventions assigned to this group

Normal

Normal controls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emanuela R Valsangiacomo Buechel, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Zürich, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Children's Hospital Zürich, Switzerland

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Atrial function in CHD by CMR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.