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Observational Study for Friedreich Ataxia Cardiomyopathy (CLARITY-FA)

This study, called CLARITY-FA, is looking at how heart disease (cardiomyopathy) progresses in people with Friedreich Ataxia (FA). It's an observational study, meaning researchers will watch and collect information about your health over time, rather than testing a specific treatment. You might be able to join if you are at least 6 years old, have a confirmed diagnosis of FA with onset before age 25, and have specific heart conditions like left ventricular hypertrophy (thickening of the heart muscle) and a left ventricular ejection fraction (a measure of how well your heart pumps blood) of 40% or higher. The main goal is to understand how heart problems develop and change over 26 weeks. After this study, you might have the chance to join another study testing a gene therapy called LX2006.

Study design
This is an observational study planning to enroll 65 participants. It is a prospective, longitudinal, multicenter study.
What's involved
Participants will be observed for at least 26 weeks to characterize cardiac disease progression.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06865482

Clinical Course Of Disease In Participants With FA-CM

Recruiting
Not specifiedAges 6+Observational
Lexeo Therapeutics
~65 participants
Updated 2026-06-08 on ClinicalTrials.gov

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterize cardiac disease presentation and progression among participants
Measured over 26 weeks

Conditions

Friedreich Ataxia
Cardiomyopathy

Explore related trials

CardiomyopathyFriedreich AtaxiaGAA expansion

Where it's being run

19 sites across 18 states
São Paulo2
California1
Florida1
Indiana1
Massachusetts1
Minnesota1
Missouri1
Ohio1

Study leadership

  • Lexeo Clinical Trials · STUDY_DIRECTOR · Lexeo Therapeutics

Who to contact

Lexeo Clinical Trials
[email protected]
212-547-9879
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Characterize cardiac disease presentation and progression among participants26 weeks

    Change from baseline in left ventricular mass index (LVMi)