Transposition of Great VesselsNCT02588989
Fibrosis, Valvular and Ventricular Function in Patients With TGA
An observational study of Transposition of Great Vessels, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transposition of Great Vessels
- How many people
- 37 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a transposition of the great arteries (TGA)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Transposition of Great Vessels
- Medical subject headings
- Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| transposition of the great arteries | Patients with a TGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Composite clinical end point
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transposition of Great VesselsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Budts, M.D., Ph.D., Principal investigator, Universitaire Ziekenhuizen KU LeuvenJan Bogaert, M.D., Ph.D., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588989
- Sponsor's protocol ID
- TGA_function
- Status last verified
- Jul 2024
- First submitted
- 22 Oct 2015
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrosis, Valvular and Ventricular Function in Patients With Transposition of the Great Arteries
- ClinicalTrials.gov ID
- NCT02588989
- Acronym / sponsor ID
- TGA_function
- Conditions
- Transposition of Great Vessels
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transposition of the great arteries | – | –Patients with a TGA |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a transposition of the great arteries (TGA)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event-free survival
Time frame: 10 years
Composite clinical end point
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Budts, M.D., Ph.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
Jan Bogaert, M.D., Ph.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transposition of Great Vessels, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.