Brief Title
Fibrosis, Valvular and Ventricular Function in Patients With TGA
Official Title
Fibrosis, Valvular and Ventricular Function in Patients With Transposition of the Great Arteries
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.
Study Type
Observational
Primary Outcome
Correlation between fibrosis and systemic right ventricular (RV) function
Secondary Outcome
Correlation between systemic RV function and systemic atrioventricular valve (SAVV) regurgitation ≥3/4
Condition
Transposition of Great Vessels
Study Arms / Comparison Groups
transposition of the great arteries
Description: Patients with a TGA
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
20
Start Date
October 2015
Completion Date
December 2026
Primary Completion Date
December 2016
Eligibility Criteria
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
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Werner Budts, M.D., Ph.D., +32 16 34 22 92, [email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02588989
Organization ID
TGA_function
Responsible Party
Sponsor
Study Sponsor
Universitaire Ziekenhuizen Leuven
Study Sponsor
Werner Budts, M.D., Ph.D., Principal Investigator, Universitaire Ziekenhuizen Leuven
Verification Date
May 2016