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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Transposition of Great Vessels

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