Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults

Transposition of the Great Arteries Clinical Trial

— ASO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02415491
• Other study ID #: 14-039
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2015
• Last updated: February 17, 2016
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2016
• Source: RWTH Aachen University
• Contact: Hedwig Hoevels- Guerich, Prof MD
• Phone: +49 241 80
• Email: hhoevels-guerich[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Bezirksregierung Köln, Dezernat 24
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 28 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Artery Switch Operation
• Transposition of Great Vessels
• Transposition of the Great Arteries

Intervention

Other:
• Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test
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.

Locations

Country	Name	City	State
Germany	University Hospital Aachen, Department od Pediatric Cardiology	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 hours	No
Primary	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.	up to 3 hours	No
Primary	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.	up to 3 hours	No
Primary	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.	up to 3 hours	No
Secondary	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.	up to 1 hour	No
Secondary	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.	up to 1 hour	No
Secondary	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.	up to 1 hour	No