NCT02588989Active, not recruitingNot Applicable
Fibrosis, Valvular and Ventricular Function in Patients With Transposition of the Great Arteries
Universitaire Ziekenhuizen KU Leuven1 site in 1 country37 target enrollmentStarted: October 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Event-free survival
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Event-free survival
Time Frame: 10 years
Composite clinical end point
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Right Ventricle Lipid in Pulmonary Arterial Hypertension (PAH)Heritable Pulmonary Arterial HypertensionPulmonary Arterial Hypertension Associated With Connective Tissue DiseaseIdiopathic Pulmonary Arterial HypertensionNCT05462574Vanderbilt University Medical Center75
Recruiting
Not Applicable
Omics in Valvular DiseaseStenosis, AorticNCT05768594Fondazione Policlinico Universitario Agostino Gemelli IRCCS30
Completed
Not Applicable
Magnetic Resonance Imaging and FibrosisHeart Valve DiseaseVentricular FunctionFibrosisNCT02790008Linkoeping University60
Recruiting
Not Applicable
PV Loop and Pulmonary HypertensionPulmonary Vascular Resistance AbnormalityNCT05484596Hythem Nawaytou65
Active, not recruiting
Not Applicable
Cardiopulmonary and Right Ventricular Function in Health and DiseaseHeart FailureAthletes HeartNCT04147299University of Colorado, Denver80