🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06865482
Recruiting Observational

Clinical Course Of Disease In Participants With FA-CM

NCT06865482 · tracked via the Priya Life Science USA tracker
Sponsor
Lexeo Therapeutics
Phase
Observational
Started
2025-09-30
Last updated
2026-09-02

Condition(s) studied

Friedreich AtaxiaCardiomyopathy

Study summary

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

Eligibility

Sex
ALL
Min age
6 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
University of California San Diego La Jolla California Recruiting
University of South Florida Tampa Florida Recruiting
Indiana University - Riley Children's Health Indianapolis Indiana Recruiting
Boston Children's Hospital Boston Massachusetts Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Washington University School of Medicine in St. Louis St Louis Missouri Recruiting
Cincinnati Children's Hospital Cincinnati Ohio Recruiting
Oregon Health & Science University Portland Oregon Recruiting
Hospital Universitário Walter Cantídio - Universidade Federal do Ceará Fortaleza Ceará Recruiting
Instituto D'or de Pesquisa e Ensino - Hospital São Rafael Salvador Estado de Bahia Recruiting
Hospital Das Clínicas Da Universidade Federal De Minas Gerais (UFMG) Belo Horizonte Minas Gerais Recruiting
Campinas State University (UNICAMP) Campinas São Paulo Recruiting
UPC Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Ribeirão Preto São Paulo Recruiting
Centre Hospitalier de Universite de Montreal (CHUM) Montreal Quebec Recruiting
Motol University Hospital and the Second Faculty of Medicine Prague Czechia Recruiting
Institut de Cardiologie Hopital Pitie Salpetriere Paris France Recruiting
University Hospital Tübingen Tübingen Baden-Wurttemberg Recruiting
Federico II University Naples Italy Recruiting
Hospital Univeritario Puerta de Hierro de Majadahonda Majadahonda Madrid Recruiting

More Lexeo Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06865482 on ClinicalTrials.gov ↗ ← All trials in the USA