ClinicalTrials.gov record NCT06956573

Aortic Dimensions in Patients With Fabry Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Aortic Dimensions in Patients With Fabry Disease

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a retrospective observational study using existing heart imaging to study the ascending aorta in people with Fabry disease. Investigators will review echocardiography and/or cardiac MRI images to measure aortic diameters. The main measurement is the maximum ascending aortic diameter expressed as a Z-score.

What it is studying. The study aims to define the characteristics, determinants, and progression of ascending aortic dilatation in adults with Fabry disease using echocardiography and/or cardiac MRI.

What the researchers hope to learn. To describe ascending aortic size and its progression in adults with Fabry disease and to identify factors associated with aortic dilatation.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • aorta imaging

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • a adult patients with genetically confirmed Fabry disease must be able to signed informed consent for participation in the study

Exclusion criteria

  • Patient refusal to participate in the study

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be asked to give consent for researchers to use and analyze existing heart imaging (echocardiography and/or cardiac MRI) to measure the size of the ascending aorta. This is a retrospective review of stored imaging data; the record does not state any new procedures, visits, or tests. Participants who do not consent or who refuse participation will not be included.

How the study is structured. A retrospective, case-only observational study that analyzes existing echocardiography and/or cardiac MRI images from adult patients with Fabry disease to measure ascending aortic diameter.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Fabry disease

Important dates

Study start
May 2, 2025 (estimated)
Primary completion
May 2, 2025 (estimated)
Study completion
May 2, 2026 (estimated)
Target enrollment
200 participants (estimated)
Last updated on registry
May 4, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Hospital, Caen
Principal investigator
Fabien LABOMBARDA, MD, PhD
University Hospital, Caen

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.

Terms used on this page · explanations by MedicalUpdates.ai

echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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