Fabry DiseaseDATA-FabNCT06956573
Aortic Dimensions in Patients With Fabry Disease
An observational study of Fabry Disease, run by University Hospital, Caen.
Trial summary
We will conduct a retrospective study aiming to define the characteristics, determinants, and progression of ascending aortic dilatation in adults with Fabry disease, using echocardiography and/or cardiac MRI Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fabry Disease
- What is being tested?
- aorta imaging
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2025to 2 May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with Fabry disease
Who may be able to join
None listed.
Who cannot join
- Patient refusal to participate in the study
About this study
We will conduct a retrospective study aiming to define the characteristics, determinants, and progression of ascending aortic dilatation in adults with Fabry disease, using echocardiography and/or cardiac MRI
- Conditions
- Fabry Disease
- Being tested
- aorta imaging
- Medical subject headings
- Fabry Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aorta imagingOther
Retrospective analysis of imaging data (echocardiography and/or cardiac MRI) in adult patients with Fabry disease to assess ascending aortic diameters.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum ascending aortic diameter measured by transthoracic echocardiography or cardiac MRI, expressed as a Z-score.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start2 May 2025 (estimated)
- Primary completion2 May 2025 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fabry DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabien LABOMBARDA, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956573
- Sponsor's protocol ID
- 5122
- Acronym
- DATA-Fab
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Dimensions in Patients With Fabry Disease
- ClinicalTrials.gov ID
- NCT06956573
- Acronym / sponsor ID
- DATA-Fab / 5122
- Conditions
- Fabry Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 May 2025 (estimated)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- 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.
We will conduct a retrospective study aiming to define the characteristics, determinants, and progression of ascending aortic dilatation in adults with Fabry disease, using echocardiography and/or cardiac MRI
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with Fabry disease
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patient refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aorta imagingRetrospective analysis of imaging data (echocardiography and/or cardiac MRI) in adult patients with Fabry disease to assess ascending aortic diameters. | Other | – |
Primary outcome
Maximum ascending aortic diameter measured by transthoracic echocardiography or cardiac MRI, expressed as a Z-score.
Time frame: At baseline
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 4 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fabry Disease, run by University Hospital, Caen.
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 0 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum ascending aortic diameter measured by transthoracic echocardiography or cardiac MRI, expressed as a Z-score. (time frame: At baseline). 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 4 May 2025.