Coarctation of the AortaNCT02161471
Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance
An observational study of Coarctation of the Aorta and Tetralogy of Fallot, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coarctation of the Aorta, Tetralogy of Fallot, Transposition of the Great Arteries
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jun 2009to 24 Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- Ability to perform repetitive breath holds of 10-15 seconds each
- Written informed consent of the patients or their legal guardians
Who cannot join
- Patients requiring general anaesthesia
- Residual cardiac findings which might potentially influence the size and function of the atria
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zürich, Switzerland
Zurich, Canton of Zurich, 8032
About this study
Official title: 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.
Read the 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.
- Keywords
- Atria, Heart, Function, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities, Congenital Abnormalities, Tetralogy, Fallot, Transposition of Great Arteries, Coarctation of the Aorta
- Medical subject headings
- Aortic Coarctation, Tetralogy of Fallot, Transposition of Great Vessels, Heart Defects, Congenital, Cardiovascular Abnormalities, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tetralogy of Fallot | Patients after repair of tetralogy of Fallot | |
| Normal | Normal controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of CMR (baseline only, no intervention)
Secondary outcomes (1)
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.
Measured: Day of CMR (baseline only, no intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start16 Jun 2009
- Primary completion24 Nov 2009
- Study completion24 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coarctation of the AortaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanuela R Valsangiacomo Buechel, Prof., Principal investigator, University Children's Hospital Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161471
- Sponsor's protocol ID
- Atrial function in CHD by CMR
- Status last verified
- Mar 2025
- First submitted
- 10 Jun 2014
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamics and Function of the Atria in Patients With Congenital Heart Defects - Pilot Study by Cardiovascular Magnetic Resonance
- ClinicalTrials.gov ID
- NCT02161471
- Acronym / sponsor ID
- Atrial function in CHD by CMR
- Keywords
- Atria, Heart, Function, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities, Congenital Abnormalities, Tetralogy, Fallot, Transposition of Great Arteries, Coarctation of the Aorta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 16 Jun 2009 (actual)
- Primary completion
- 24 Nov 2009 (actual)
- Study completion
- 24 Nov 2009 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetralogy of Fallot | – | –Patients after repair of tetralogy of Fallot |
| Normal | – | –Normal controls |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Ability to perform repetitive breath holds of 10-15 seconds each
- Written informed consent of the patients or their legal guardians
Key exclusion criteria (2 listed)
- Patients requiring general anaesthesia
- Residual cardiac findings which might potentially influence the size and function of the atria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Right and left atrial volume
Time frame: 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.
1 secondary outcome
Blood flow across the atrio-ventricular valves
Time frame: Day of CMR (baseline only, no intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuela R Valsangiacomo Buechel, Prof. principal investigator
University Children's Hospital Zürich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coarctation of the Aorta and Tetralogy of Fallot, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right and left atrial volume (time frame: Day of CMR (baseline only, no intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.