Can MRI reveal if enzyme therapy protects hearts in fabry disease?
NCT ID NCT02956954
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study followed 26 people with Anderson-Fabry disease, some taking the enzyme replacement drug Replagal® and some not, to see how their hearts changed over two years. Researchers used special MRI scans to measure heart tissue relaxation time, which may indicate early damage. The goal was to find a better way to monitor whether treatment is protecting the heart.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Agalsidase alpha (Replagal®)
- What this could lead to
- If successful, this could show that Replagal® improves heart structure and function in Fabry disease, offering a way to monitor treatment effectiveness with MRI.
- What could go wrong
- This is a small, observational study with only 26 patients, so results may not apply to everyone. It does not test a new treatment, only tracks existing therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
26 people
The number who actually took part.
- Started
-
Mar 2017
- Finished
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Jan 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient with proven Anderson Fabry Disease * Patient with no Agalsidase alpha (Replagal®) treatment or * Patient with Agalsidase alpha (Replagal®) treatment ongoing Exclusion Criteria: * Pace Maker / Implantable Cardiac Defibrillator * Claustrophobia * Ocular foreign body * Allergy to gadolinium chelates * Pregnancy ongoing * Age \< 18 years l
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Rouen University Hospital
Rouen, France
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Other studies related to the condition(s) this trial covers.