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Clinical Trials/NCT02588989
NCT02588989
Active, not recruiting
Not Applicable

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

Universitaire Ziekenhuizen KU Leuven1 site in 1 country37 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transposition of Great Vessels
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
37
Locations
1
Primary Endpoint
Event-free survival
Status
Active, not recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
June 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Event-free survival

Time Frame: 10 years

Composite clinical end point

Study Sites (1)

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