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NCT02588989 Clinical Trial

Fibrosis, Valvular and Ventricular Function in Patients With TGA

Transposition of Great Vessels Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02588989
Other study ID # TGA_function
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2015
Est. completion date June 2027

Study information
Verified date May 2017
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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 information / eligibility
Status Active, not recruiting
Enrollment 37
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium University Hospitals Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event-free survival Composite clinical end point 10 years
See also
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Completed NCT05160116 - Influence of Timing of Switch Operation in Transposition of Great Arteries
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