Status:
RECRUITING
CVI Alterations in FD: a Prospective, Multicenter, Observational Cohort Study
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Fabry Disease, Cardiac Variant
Eligibility:
All Genders
18+ years
Brief Summary
Fabry disease (FD) is a rare X-linked lysosomal storage disorder caused by α-galactosidase A (GLA) gene mutations leading to reduced or undetectable α galactosidase A (α-Gal A) enzyme activity, result...
Eligibility Criteria
Inclusion
- Patients to be enrolled in this study should fulfill all 3 criteria (a, b, and c) at screening:
- Patients with a maximum myocardial wall thickness (left ventricular posterior wall or septum) of ≥13 mm at the end diastole on echocardiography;
- At least two or more "warning signs" associated with FD ("warning signs" include cardiac "warning signs", extracardiac "warning signs", or family history)
- Aged 18 years old or older;
- cardiac "warning signs" of FD:
- Concentric LVH or papillary hypertrophy or right ventricular hypertrophy on echocardiography
- ECG abnormalities (eg, shortened PR interval, wide QRS complex, right bundle branch block, ST-segment depression, etc.)
- Extra-cardiac "warning signs" of FD
- Angiokeratomas
- Acroparesthesia
- Hypohidrosis
- Premature stroke (\<50 years of age)
- Corneal verticillate
- Renal impairment accompanied by proteinuria
- Hearing loss
- Family history
- Family history of X-linked inherited disorder (renal disease or cardiac disease)
Exclusion
- LVH patients with a clear etiology;
- Combining any other clinical condition with a life expectancy less than 1 year;
- Refuse to give informed consent or refuse to be followed-up.
Key Trial Info
Start Date :
December 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06512571
Start Date
December 31 2024
End Date
December 30 2026
Last Update
March 26 2025
Active Locations (1)
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1
Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China, 100037