Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT03305250
Eligibility Criteria:
Inclusion Criteria:
* Patients with genotypically or enzymatically confirmed FD
* Adults \> 18 years of age
* Evidence of cardiac involvement from FD involving either:
* Any ECG abnormality associated with FD
* Low T1 on CMR (below centre-specific normal range according to sex)
* LVH on transthoracic echo (defined as MWT \>12mm)
Exclusion Criteria:
* Patient with an existing cardiac device (PPM, ICD or ILR).
* Known dual pathology:
* Known coronary artery disease (positive non-invasive imaging, confirmed myocardial infarction, percutaneous or surgical revascularisation). Patients \>40 years old with symptoms that could be from coronary artery disease will have this excluded
* Known cardiomyopathy disease causing mutation (e.g. SCN5, MYBPC3)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03305250
Study Brief:
Protocol Section:
NCT03305250