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

NCT02415491 | Unknown

• 1 other identifier: 14-039
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Transposition of the Great Arteries; Artery Switch Operation

Keywords

TGA; ASO; magnetic resonance imaging (MRI); young adulthood

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• Breathing minute volume (VE l/min)

  up to 1 hour

• Peak oxygen uptake (VO2 in %)

  up to 1 hour

• Forced vital capacity (in %)

  up to 1 hour

Study Arms (1)

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

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

Interventions

Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test OTHER

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.

ASO group

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital Aachen, Department od Pediatric Cardiology

Aachen, 52074, Germany

RECRUITING

MeSH Terms

Conditions

Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hedwig Hoevels-Guerich, Prof MD

  Department od Pediatric Cardiology, University Hospital Aachen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hedwig Hoevels- Guerich, Prof MD

CONTACT

+49 241 80; hhoevels-guerich@ukaachen.de

Angela Habier, M. Sc.

CONTACT

+49 241 80; ahabier@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 14, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

DE (1)