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:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT04129905
Eligibility Criteria:
Inclusion Criteria:
* Patients and volunteers:
* Adults (age ≥18 years), male or female,
* For female in age, efficient contraception will be required and a negative pregnancy test will be required,
* Signed informed consent form will required for each included subject after having read the information note,
* Affiliated to the national social security system,
* Patients:
.Patients diagnosed to have HCM secondary to sarcomeric mutation or to Fabry disease, symptomatic (dyspnea on exertion and/or chest pains during exercise),
* Healthy volunteers:
* Subjects without known cardiac disease,
* No smokers.
Exclusion Criteria:
* Patients and volunteers:
* No cardiac pathology reducing life expectancy to less than 12 months (cancer),
* Unbalanced arterial hypertension (systolic \>160 mmHg and/or diastolic \>120 mmHg),
* Pregnancy or breastfeeding,
* Major obesity \> 140 kg,
* Impossibility or refusal to give or sign the consent form,
* Subject in period of exclusion relative to an other protocol,
* Subject deprived of liberty by judicial or administrative decision,
* Major protected by the Law
* Patients:
* Atrial fibrillation at the time of inclusion
* Valvulopathy with severity greater than moderate.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04129905
Study Brief:
Protocol Section:
NCT04129905