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This is a prospective, multicenter, observational study examining alterations referred to as CVI in people who have or are suspected of having Fabry disease. It enrolls patients aged 18 and older who have increased heart muscle wall thickness and warning signs of Fabry disease. It is a study with no assigned phase and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
Patients to be enrolled in this study should fulfill all 3 criteria (a, b, and c) at screening:
1. Patients with a maximum myocardial wall thickness (left ventricular posterior wall or septum) of ≥13 mm at the end diastole on echocardiography;
2. At least two or more "warning signs" associated with FD ("warning signs" include cardiac "warning signs", extracardiac "warning signs", or family history)
3. 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 Criteria:
1. LVH patients with a clear etiology;
2. Combining any other clinical condition with a life expectancy less than 1 year;
3. Refuse to give informed consent or refuse to be followed-up.