Sophisticated Assessment of Disease Burden in Patients With Fabry Disease (SOPHIA)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Sophisticated Assessment of Disease Burden in Patients With Fabry Disease - The SOPHIA in Fabry Disease Study|
- Number of fibrotic left ventricular segments at baseline and after 12 and 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Left ventricular mass at 12 and 24 months compared to baseline assessed by MRI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|mild affected Fabry patients||
Cardiac MRI after 12 and 24 months.
Other Name: MRT (German)
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.
|Contact: Martina Kralewski, Dr.||0049(0)152 ext firstname.lastname@example.org|
|University of Mainz||Recruiting|
|Mainz, Germany, 55131|
|Contact: Christoph Kampmann, Prof. Dr. 0049(0)6131 ext 172783 email@example.com|
|Principal Investigator: Christpoh Kampmann, Prof. Dr.|
|Principal Investigator:||Christoph Kampmann, Prof. Dr.||University of Mainz, Germany|