UnknownNot Applicable

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

Germany100 participantsStarted 2015-05

Plain-language 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.

Who can participate

Age range

18 Years – 28 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ejection Fraction (EF)

Timeframe: up to 3 hours

Heart rate (HR)

Timeframe: up to 3 hours

Wall motion

Timeframe: up to 3 hours

Pulmonary ventilation/pulmonary blood flow (V/Q in l/min)

Timeframe: up to 3 hours

Trial details

NCT IDNCT02415491

SponsorRWTH Aachen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11

Contact for this trial

Hedwig Hoevels- Guerich, Prof MD

+49 241 80 hhoevels-guerich@ukaachen.de

View on ClinicalTrials.gov More Transposition of the Great Arteries trials

Who can participate

Age range

18 Years – 28 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.