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Study Based on Electronic Health RecOrds to Identify Patients at High-risk of Fabry DiseasE (HOPE Fabry)
Study Based on Electronic Health RecOrds to Identify Patients at High-risk of Fabry DiseasE (HOPE Fabry)

NCT05671770

CompletedN/A

Sponsor: Sanofi

Conditions: Fabry Disease

Countries: United Arab Emirates

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (1)
  • Abu Dhabi, United Arab Emirates