- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02588989
Fibrosis, Valvular and Ventricular Function in Patients With TGA
January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
Fibrosis, Valvular and Ventricular Function in Patients With Transposition of the Great Arteries
The aim of this project is to better evaluate the systemic right ventricular (RV) function in patients with transposition of the great arteries (TGA).
Study Overview
Status
Active, not recruiting
Conditions
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
Enrollment (Actual)
37
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leuven, Belgium, 3000
- University Hospitals Leuven
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with a transposition of the great arteries (TGA)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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transposition of the great arteries
Patients with a TGA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free survival
Time Frame: 10 years
|
Composite clinical end point
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Werner Budts, M.D., Ph.D., Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Jan Bogaert, M.D., Ph.D., Universitaire Ziekenhuizen KU Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Anticipated)
June 1, 2027
Study Completion (Anticipated)
June 1, 2027
Study Registration Dates
First Submitted
October 22, 2015
First Submitted That Met QC Criteria
October 26, 2015
First Posted (Estimate)
October 28, 2015
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TGA_function
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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