Primary objective:

To estimate the prevalence of patients who are at high-risk for Fabry Disease (FD) in the Cleveland Clinic, Abu Dhabi (CCAD) United Arab Emirates (EMR) database from May 2016 to May 2022, according to the predictive algorithm (i.e., feasibility assessment eligibility criteria)

Secondary objectives:

• To estimate the prevalence of FD among patients at high-risk for FD (i.e., among enrolled patients)
• To characterize the patient profile, overall and in Cohorts 1 and 2
• To describe the most common characteristics among positive FD patients and negative FD patients

Patients at high-risk for FD will be consecutively enrolled over approximately 6 months

Inclusion Criteria:

• Patients who were identified as high-risk for FD via the predictive algorithm per the feasibility assessment
• Patients who have signed an informed consent form

Cohort 1 (chronic kidney disease)

• Adult male patient ≤60 years old or adult female patient of any age

• Having chronic kidney disease

• Having proteinuria

• Having one or more of the following conditions:

  • Neuralgia and neuritis, unspecified
  • Disturbances in skin sensation
  • Anhidrosis, and
  • Hypertrophic cardiomyopathy.

Cohort 2 (hypertrophic cardiomyopathy)

• Adult male patient ≤50 years old or adult female patient of any age

• Having hypertrophic cardiomyopathy

• Having one or more of the following conditions:

  • transient cerebral ischemic attack,
  • chronic kidney disease.

Exclusion Criteria:

• Patients with an established diagnosis of FD.
• Pregnant subject at the time of the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Patients with chronic kidney disease (Cohort 1) or hypertrophic cardiomyopathy (Cohort 2), who fulfill the criteria for being at high-risk for FD, per the predictive algorithm, and provide informed consent, will be eligible to participate in this study.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org