Status:
UNKNOWN
RAMYD Study - Evaluation of Arrhythmic Risk in Myotonic Dystrophy
Lead Sponsor:
Catholic University of the Sacred Heart
Collaborating Sponsors:
Fondazione Telethon
Conditions:
Myotonic Dystrophy
Sudden Cardiac Death
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This is a prospective multicentric Italian study to evaluate the arrhythmic risk in myotonic dystrophy type 1.
Detailed Description
Myotonic dystrophy type 1 (DM1, Steinert disease) is a multisystem disorder that affects, beside muscle, several other organs, including the heart. Cardiac involvement represents a major problem in t...
Eligibility Criteria
Inclusion
- Patient affected by myotonic dystrophy type I (MD1).
- Patient willing to provide a signed informed consent.
Exclusion
- Age \< 18 years old or \>70 years old.
- Ischemic cardiomyopathy
- Cardiomyopathy due to chronic excess of alcohol consumption (\>100 g\\day)
- Congenital heart disease
- Acquired valvular heart disease
- Metabolic cardiomyopathy: thyrotoxicosis, hypothyroidism, adrenal cortical insufficiency, pheochromocytoma, acromegaly
- Familiar storage and infiltrative diseases (hemochromatosis, glycogen storage, Hurler's syndrome, Niemann-Pick disease; primary, secondary, familial and hereditary cardiac amyloidoses)
- Systemic diseases (connective tissue disorder; sarcoidosis)
- Peripartum cardiomyopathy
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
537 Patients enrolled
Trial Details
Trial ID
NCT00127582
Start Date
January 1 2003
Last Update
August 25 2005
Active Locations (1)
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1
Catholic University of Sacred Heart
Rome, Rome, Italy, 00168