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Fibrosis, Valvular and Ventricular Function in Patients With TGA

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02588989
Enrollment
37
Registered
2015-10-28
Start date
2015-10-31
Completion date
2027-06-30
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transposition of Great Vessels

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.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Event-free survival10 yearsComposite clinical end point

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026