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Clinical Course Of Disease In Participants With FA-CM

RecruitingObservational study

Characteristics And Clinical Course Of Disease In Participants With Cardiomyopathy Associated With Friedreich Ataxia (CLARITY-FA)

Who can join

Ages 6 and older · All sexes

Full 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 ≥30%

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

About the study

Characteristics and clinical course of disease In participants with cardiomyopathy associated with Friedreich Ataxia (CLARITY-FA)

Sponsor: Lexeo Therapeutics · Participants: 65 · Started: Sep 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06865482

Locations in the U.S.

CaliforniaUniversity of California San Diego, La Jolla
FloridaUniversity of South Florida, Tampa
IndianaIndiana University - Riley Children's Health, Indianapolis
MassachusettsBoston Children's Hospital, Boston
MinnesotaMayo Clinic, Rochester
MissouriWashington University School of Medicine in St. Louis, St Louis
OhioCincinnati Children's Hospital, Cincinnati
OregonOregon Health & Science University, Portland

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.