Fibrosis, Valvular and Ventricular Function in Patients With TGA

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Transposition of great arteries
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Brief Title

Fibrosis, Valvular and Ventricular Function in Patients With TGA

Official Title

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

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 Type

Observational

Primary Outcome

Correlation between fibrosis and systemic right ventricular (RV) function

Secondary Outcome

 Correlation between systemic RV function and systemic atrioventricular valve (SAVV) regurgitation ≥3/4

Condition

Transposition of Great Vessels

Study Arms / Comparison Groups

 transposition of the great arteries
Description:  Patients with a TGA

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

20

Start Date

October 2015

Completion Date

December 2026

Primary Completion Date

December 2016

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

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Werner Budts, M.D., Ph.D., +32 16 34 22 92, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT02588989

Organization ID

TGA_function

Responsible Party

Sponsor

Study Sponsor

Universitaire Ziekenhuizen Leuven

Study Sponsor

Werner Budts, M.D., Ph.D., Principal Investigator, Universitaire Ziekenhuizen Leuven

Verification Date

May 2016