NCT05671770Completed
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
Source: ClinicalTrials.gov · Last updated 6 Mar 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 15 (actual)
- First submitted
- 20 Dec 2022
- Start date
- 28 Jul 2023
- Primary completion date
- 14 Dec 2023
- Lead sponsor
- Sanofi
- Diseases
- Fabry disease
- NCT number
- NCT05671770
What you commit to
- Study type: Observational
- Participants enrolled: 15
- From 28 Jul 2023 to the primary completion date, 14 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic AbuDhabi Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.