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โ† Trials
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Clinical Course Of Disease In Participants With FA-CM

Recruitingn/aAges 6 Years - anyAllLexeo Therapeutics
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female, ages โ‰ฅ6 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 โ‰ค25 years of age * Confirmed left ventricular hypertrophy (LVH) * Left ventricular ejection fraction โ‰ฅ30% 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 โ‰ฅ8%) * Active hematologic or solid organ malignancy
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What it tests

  • Not listed
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Where

19 sites
University of California San Diego
La Jolla, United States
University of South Florida
Tampa, United States
Indiana University - Riley Children's Health
Indianapolis, United States
Boston Children's Hospital
Boston, United States
Mayo Clinic
Rochester, United States
Washington University School of Medicine in St. Louis
St Louis, United States
Cincinnati Children's Hospital
Cincinnati, United States
Oregon Health & Science University
Portland, United States

โ€ฆand 11 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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