Clinical trial NCT02415491: Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transposition of the Great Arteries
Artery Switch Operation
Keywords: TGA
ASO
magnetic resonance imaging (MRI)
young adulthood
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ejection Fraction (EF)
timeFrame: up to 3 hours
measure: Heart rate (HR)
timeFrame: up to 3 hours
measure: Wall motion
timeFrame: up to 3 hours
measure: Pulmonary ventilation/pulmonary blood flow (V/Q in l/min)
timeFrame: up to 3 hours
Secondary outcomes:
measure: Breathing minute volume (VE l/min)
timeFrame: up to 1 hour
measure: Peak oxygen uptake (VO2 in %)
timeFrame: up to 1 hour
measure: Forced vital capacity (in %)
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen, Department od Pediatric Cardiology
Study officials:
affiliation: Department od Pediatric Cardiology, University Hospital Aachen
name: Hedwig Hoevels-Guerich, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: