Fibrosis, Valvular and Ventricular Function in Patients With TGA

N/AActive Not RecruitingNCT02588989

Universitaire Ziekenhuizen KU Leuven37 enrolled

Overview

The aim of this project is to better evaluate the systemic right ventricular (RV) function in patients with transposition of the great arteries (TGA).

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

Enrollment

Conditions

Transposition of Great Vessels

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Event-free survival

Composite clinical end point

Time frame: 10 years

Data from ClinicalTrials.gov

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