Fibrosis, Valvular and Ventricular Function in Patients With TGA
Active, not recruiting
- Conditions
- Transposition of Great Vessels
- Registration Number
- NCT02588989
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
The aim of this project is to better evaluate the systemic right ventricular (RV) function in patients with transposition of the great arteries (TGA).
- Detailed Description
Patients with TGA frequently develop supraventricular and ventricular arrhythmia, conduction problems, systemic atrioventricular valve (SAVV) regurgitation, and congestive heart failure (CHF), all at young age. However, there is variation in time of onset of these adverse events. We want to evaluate ventricular and valvular function at rest, markers of RV fibrosis and cardiac reserve.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
- Patients with a TGA
- Informed consent to participate. If the patient is under the age of 18, the assent of the patient and the permission of the parents to participate
Exclusion Criteria
- Previous double-switch intervention
- Any medical contra-indication for cardiovascular magnetic resonance (CMR) imaging (e.g. pacemaker)
- The presence of exercise-induced arrhythmia, symptomatic myocardial ischemia, a resting systolic blood pressure > 200 mm Hg and/or diastolic blood pressure > 110 mm Hg, New York Heart Association (NYHA) class III or IV, or non-cardiac co-morbidity that could aggravate by exercise
- Additional exclusion criterion for delayed gadolinium enhancement CMR: any medical contra-indication for intravenous gadolinium
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival 10 years Composite clinical end point
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospitals Leuven
🇧🇪Leuven, Belgium