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NCT06865482
Clinical Course Of Disease In Participants With FA-CM
Conditions: Friedreich Ataxia, Cardiomyopathy
Sex: All
Ages: 6 Years – N/A
Healthy volunteers: No
Enrollment: 65
Sponsor: Lexeo Therapeutics
Location: University of California San Diego La Jolla California
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 \
Source: ClinicalTrials.gov (NCT06865482). StuddyBuddy aggregates publicly available trial information.