Transposition of the Great ArteriesASONCT02415491
Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults
A study testing Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test in people with Transposition of the Great Arteries and Artery Switch Operation, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of the great arteries. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Transposition of the Great Arteries, Artery Switch Operation
- What is being tested?
- Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Nov 2016
- Phase
- Interventional
- 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 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- former EMAH (adults with congenital heart defects) patients > 18 years old
- after neonatal ASO for TGA at the Department of pediatric cardiac surgery
- also if applicable with a correction of an aorta isthmus stenosis neotal or in infancy
Who cannot join
- contraindications of MRI as metallic implants, claustrophobia
- contraindications of MRI contrast agents
- severe chronic kidney disease (estimated glomerular filtration rate < 30 ml/min)
- contraindications of exercise stress test with dobutamine or cardiopulmonary exercise stress test (e.g. instable angina pectoris, complex arrhythmia)
- disabled persons not able to perform cardiopulmonary exercise stress test
- pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Aachen, Department od Pediatric Cardiology
Aachen, 52074
Hedwig Hoevels-Guerich, Prof., 004924180 ext. 36253, hhoevels-guerich@ukaachen.de
Angela Habier, 004924180 ext. 37429, ahabier@ukaachen.de
About this study
Official title: Cardiovascular Magnetic Resonance at Rest and Stress in Relation to Cardiopulmonary Exercise Capacity in Young Adults After Arterial Switch Operation (ASO) for Transposition of the Great Arteries (TGA)
Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of the great arteries.
Read the detailed description
After ASO obstruction of the transposed coronary arteries with resulting reduced perfusion of the heart at stress or abnormities of the right ventricular blood flow resulting in increasing heart rate as well as abnormities in pulmonary flow can appear. In this single centre trial a large homogeneous group of young adults after surgery for transposition of the great arteries (TGA), the so called artery switch operation (ASO), will undergo magnetic resonance imaging (MRI) of the heart at rest and under drug- induced stress to receive data of the functional status of the heart and its perfusion as well as data of the pulmonary arterial perfusion.
Also obstruction of the pulmonary arteries will lead to reduced perfusion and cardiopulmonary exercise capacity.
Therefore the MRI data will be compared to cardiopulmonary exercise capacity data determined by cardio pulmonary stress test (CPX) concerning the feasibility of a correlation of the data and possible generalisation of the results leading to long term assessment of coronary perfusion and myocardial status after ASO for recommendations of physical activity of the young adults.
- Being tested
- Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test
- Keywords
- TGA, ASO, magnetic resonance imaging (MRI), young adulthood
- Medical subject headings
- Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress testOther
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of pulmonary perfusion.
Afterwards induced stress MRI will be performed according to standard protocol with elevation of dobutamine levels until the reach of peak HR. If applicable the procedure will be stopped) in case of e.g. arrhythmia.
Cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer, the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg to 3 watt/kg over 10 minutes. Electrocardiography and heart rate will be taken continuously during and until 10 minutes afterwards. Blood pressure will be taken before, during and after the stress test. Respiratory gas exchange parameters will be taken continuously, peak oxygen uptake (VO2) determined as well as Ventilatory Efficiency.
| Study group | Role | What they receive |
|---|---|---|
| ASO group | Experimental | ASO group:Evaluation of Correlation of Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test for long term assessment after ASO and recommendation of physical activity of young adults after TGA Receives: Other: Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection Fraction (EF)
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of the ejection fraction.
Afterwards induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Measured: up to 3 hours
Heart rate (HR)
MRI at rest will be performed, afterwards induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Measured: up to 3 hours
Wall motion
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of wall motions.
Induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Measured: up to 3 hours
Pulmonary ventilation/pulmonary blood flow (V/Q in l/min)
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of pulmonary perfusion.
Afterwards induced stress MRI will be performed according to standard protocol with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram/kg/min until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Measured: up to 3 hours
Secondary outcomes (3)
Breathing minute volume (VE l/min)
cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer and the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg to 3 watt/kg over 10 minutes. Electrocardiography and heart rate will be taken continuously during and until 10 minutes afterwards. Blood pressure will be taken before, during and after the stress test.
Measured: up to 1 hour
Peak oxygen uptake (VO2 in %)
cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer and the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg t0 3 watts/kg over 10 minutes. Electrocardiography and heart rate will be taken continuously during and until 10 minutes afterwards. Blood pressure will be taken before, during and after the stress test. Respiratory gas exchange parameters will be taken continuously, peak VO2 determined.
Measured: up to 1 hour
Forced vital capacity (in %)
cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer and the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg t0 3 watt/kg over 10 minutes. Electrocardiography and heart rate will be taken continuously during and until 10 minutes afterwards. Blood pressure will be taken before, during and after the stress test. Respiratory gas exchange parameters will be taken, forced vital capacity determined.
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transposition of the Great ArteriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hedwig Hoevels-Guerich, Prof MD, Principal investigator, Department od Pediatric Cardiology, University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415491
- Sponsor's protocol ID
- 14-039
- Acronym
- ASO
- Status last verified
- Feb 2016
- First submitted
- 1 Apr 2015
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Magnetic Resonance at Rest and Stress in Relation to Cardiopulmonary Exercise Capacity in Young Adults After Arterial Switch Operation (ASO) for Transposition of the Great Arteries (TGA)
- ClinicalTrials.gov ID
- NCT02415491
- Acronym / sponsor ID
- ASO / 14-039
- Keywords
- TGA, ASO, magnetic resonance imaging (MRI), young adulthood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 14 Apr 2015 (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.
Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of the great arteries.
Detailed description
After ASO obstruction of the transposed coronary arteries with resulting reduced perfusion of the heart at stress or abnormities of the right ventricular blood flow resulting in increasing heart rate as well as abnormities in pulmonary flow can appear. In this single centre trial a large homogeneous group of young adults after surgery for transposition of the great arteries (TGA), the so called artery switch operation (ASO), will undergo magnetic resonance imaging (MRI) of the heart at rest and under drug- induced stress to receive data of the functional status of the heart and its perfusion as well as data of the pulmonary arterial perfusion.
Also obstruction of the pulmonary arteries will lead to reduced perfusion and cardiopulmonary exercise capacity.
Therefore the MRI data will be compared to cardiopulmonary exercise capacity data determined by cardio pulmonary stress test (CPX) concerning the feasibility of a correlation of the data and possible generalisation of the results leading to long term assessment of coronary perfusion and myocardial status after ASO for recommendations of physical activity of the young adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASO group | Experimental | Other: Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress testASO group:Evaluation of Correlation of Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test for long term assessment after ASO and recommendation of physical activity of young adults after TGA |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- former EMAH (adults with congenital heart defects) patients > 18 years old
- after neonatal ASO for TGA at the Department of pediatric cardiac surgery
- also if applicable with a correction of an aorta isthmus stenosis neotal or in infancy
Key exclusion criteria (6 listed)
- contraindications of MRI as metallic implants, claustrophobia
- contraindications of MRI contrast agents
- severe chronic kidney disease (estimated glomerular filtration rate < 30 ml/min)
- contraindications of exercise stress test with dobutamine or cardiopulmonary exercise stress test (e.g. instable angina pectoris, complex arrhythmia)
- disabled persons not able to perform cardiopulmonary exercise stress test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress testMRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of pulmonary perfusion. Afterwards induced stress MRI will be performed according to standard protocol with elevation of dobutamine levels until the reach of peak HR. If applicable the procedure will be stopped) in case of e.g. arrhythmia. Cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer, the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg to 3 watt/kg over 10 minutes. Electrocardiography and heart rate will be taken continuously during and until 10 minutes afterwards. Blood pressure will be taken before, during and after the stress test. Respiratory gas exchange parameters will be taken continuously, peak oxygen uptake (VO2) determined as well as Ventilatory Efficiency. | Other | ASO group |
Primary outcome
Ejection Fraction (EF)
Time frame: up to 3 hours
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of the ejection fraction. Afterwards induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Heart rate (HR)
Time frame: up to 3 hours
MRI at rest will be performed, afterwards induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Wall motion
Time frame: up to 3 hours
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of wall motions. Induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Pulmonary ventilation/pulmonary blood flow (V/Q in l/min)
Time frame: up to 3 hours
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of pulmonary perfusion. Afterwards induced stress MRI will be performed according to standard protocol with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram/kg/min until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
3 secondary outcomes
Breathing minute volume (VE l/min)
Time frame: up to 1 hour
Peak oxygen uptake (VO2 in %)
Time frame: up to 1 hour
Forced vital capacity (in %)
Time frame: up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
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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.
Hedwig Hoevels-Guerich, Prof MD principal investigator
Department od Pediatric Cardiology, University Hospital Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test in people with Transposition of the Great Arteries and Artery Switch Operation, run by RWTH Aachen University at 1 site in Germany.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Feb 2016. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hedwig Hoevels- Guerich, Prof MD (+49 241 80 ext. 36253, hhoevels-guerich@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ejection Fraction (EF) (time frame: up to 3 hours). The study lists 4 primary outcomes in all. 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 18 Feb 2016.