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Clinical Trials/NCT02588989
NCT02588989Active, not recruitingNot Applicable

Fibrosis, Valvular and Ventricular Function in Patients With Transposition of the Great Arteries

Universitaire Ziekenhuizen KU Leuven1 site in 1 country37 target enrollmentStarted: October 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
37
Locations
1
Primary Endpoint
Event-free survival

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Event-free survival

Time Frame: 10 years

Composite clinical end point

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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