NCT06865482 Clinical Course Of Disease In Participants With FA-CM
| NCT ID | NCT06865482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lexeo Therapeutics |
| Condition | Friedreich Ataxia |
| Study Type | OBSERVATIONAL |
| Enrollment | 65 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 65 participants in total. It began in 2025-09-30 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Characteristics and clinical course of disease In participants with cardiomyopathy associated with Friedreich Ataxia (CLARITY-FA)
Eligibility Criteria
Inclusion Criteria: * Male or female, ages ≥6 years at the time of signing the informed consent (and assent, if applicable). * Diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on both alleles or compound heterozygous), with onset of FA occurring at ≤25 years of age * Confirmed left ventricular hypertrophy (LVH) * Left ventricular ejection fraction ≥40% Exclusion Criteria: * Presence of other form(s) of CM contributing to heart failure (HF), clinically significant cardiac anatomic abnormality or congenital cardiac malformation, clinically significant coronary artery, uncorrected, hemodynamically significant primary structural valvular disease not due to CM * Currently receiving intermittent or continuous intravenous (IV) inotrope infusion, presence of a ventricular assist device, or history of prior heart transplantation * Contraindication to cMRI, participants \<12 years of age who cannot complete the cMRI without sedation will instead undergo ECHOs and are exempt from this criterion. * Prior organ transplantation * Initiation of cardiac resynchronization therapy (CRT) within 6 months prior to screening. * History of prior gene transfer or cell therapy. * Poorly controlled diabetes (hemoglobin A1c ≥8%) * Active hematologic or solid organ malignancy
Contact & Investigator
Lexeo Clinical Trials
STUDY DIRECTOR
Lexeo Therapeutics
Frequently Asked Questions
Who can join the NCT06865482 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Friedreich Ataxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06865482 currently recruiting?
Yes, NCT06865482 is actively recruiting participants. Contact the research team at clinicaltrials@lexeotx.com for enrollment information.
Where is the NCT06865482 trial being conducted?
This trial is being conducted at La Jolla, United States, Tampa, United States, Indianapolis, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT06865482 clinical trial?
NCT06865482 is sponsored by Lexeo Therapeutics. The principal investigator is Lexeo Clinical Trials at Lexeo Therapeutics. The trial plans to enroll 65 participants.