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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT02840669
Eligibility Criteria:
Inclusion Criteria (Friedreich's Ataxia):
* Males and females;
* ≥ 18 years old;
* Willing and able to provide informed consent;
* Definitive diagnosis of FA, based on clinical phenotype and genotype;
* With a hypertrophic cardiomyopathy;
* Ability to complete study assessments.
Exclusion Criteria (Friedreich's Ataxia):
* Symptoms of cardiac failure;
* Moderate to severe atrial or ventricular arrhythmias;
* History of angina pectoris;
* Inability to undergo cardiac MRI;
* Clinical history or evidence of diabetes;
* Abnormal kidney function;
* Females who are pregnant or nursing;
* Receipt of an investigational drug within 30 days or 5 half-lives, or active enrollment in an investigational medication or device study;
* Inability to sit with back support;
* Inability to undergo exercise test;
* Inability to comply with all study requirements;
* Unaffiliated to any French health insurance or equivalent.
Inclusion Criteria (Healthy Volunteers):
* Healthy males and females;
* ≥ 18 years old;
* Willing and able to provide informed consent;
* Age and gender matched to the Friedreich's Ataxia group;
* Ability to complete study assessments.
Exclusion Criteria (Healthy Volunteers):
* Inability to undergo cardiac MRI;
* Clinical history or evidence of diabetes;
* Abnormal kidney function;
* Females who are pregnant or nursing;
* Receipt of an investigational drug within 30 days or 5 half-lives, or active enrollment in an investigational medication or device study;
* Inability to undergo exercise test;
* Inability to comply with all study requirements;
* Unaffiliated to any French health insurance or equivalent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02840669
Study Brief:
Protocol Section:
NCT02840669