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 @ 10:39 PM
Ignite Modification Date:
2025-12-24 @ 10:39 PM
NCT ID:
NCT06345235
Eligibility Criteria:
Inclusion Criteria:
the study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3, n=20)
1. age over 18
2. expressing informed written consent
3. clinical criteria (one of the following for a given group):
1. ATTR cardiomyopathy (GROUP 1),
2. asymptomatic carrier of the pathogenic variant of the TTR gene (GROUP 2),
3. no diagnosed ATTR cardiomyopathy and no pathogenic variant of the TTR gene (GROUP 3).
Exclusion criteria:
1. age under 18 years of age
2. failure to provide informed written consent
3. pregnancy and lactation
Exclusion Criteria:
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06345235
Study Brief:
Protocol Section:
NCT06345235