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CompletedNCT01210196

Sophisticated Assessment of Disease Burden in Patients With Fabry Disease

Sophisticated Assessment of Disease Burden in Patients With Fabry Disease - The SOPHIA in Fabry Disease Study

Status
Completed
Phase
Study type
Observational
Enrollment
36 (actual)
Sponsor
Shire · Industry
Sex
All
Age
25 Years
Healthy volunteers
Not accepted

Summary

To detect early signs of cardiac and metabolic alterations as well as to evaluate the progression of cardiac and metabolic impairments in mildly affected patients with Fabry Disease using high sensitive diagnostic methods.

Detailed description

Observational Study Evaluating the use of cardiac MRI with late enhancement technique, Echocardiography, 24h Holter ECG, plasma Lyso-Gb3 and urinary Gb3, to identify early signs of progressive Fabry Disease.

Conditions

Interventions

TypeNameDescription
PROCEDUREMRICardiac MRI after 12 and 24 months.

Timeline

Start date
2010-10-31
Primary completion
2013-09-30
Completion
2013-09-30
First posted
2010-09-28
Last updated
2021-06-03

Locations

11 sites across 6 countries: Belgium, Czechia, Denmark, Finland, Germany, Sweden

Source: ClinicalTrials.gov record NCT01210196. Inclusion in this directory is not an endorsement.