Actively Recruiting
Clinical Course Of Disease In Participants With FA-CM
Led by Lexeo Therapeutics · Updated on 2026-04-15
65
Participants Needed
14
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Characteristics and clinical course of disease In participants with cardiomyopathy associated with Friedreich Ataxia (CLARITY-FA)
CONDITIONS
Official Title
Clinical Course Of Disease In Participants With FA-CM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 6 years or older at the time of consent
- Diagnosis of Friedreich Ataxia confirmed by clinical signs and genetic testing showing GAA expansion on both alleles or compound heterozygous
- Onset of Friedreich Ataxia at age 25 years or younger
- Confirmed left ventricular hypertrophy (LVH)
- Left ventricular ejection fraction of 40% or higher
You will not qualify if you...
- Other forms of cardiomyopathy causing heart failure
- Significant cardiac structural abnormalities or congenital heart defects
- Significant coronary artery disease or untreated primary structural valve disease not caused by cardiomyopathy
- Currently receiving intermittent or continuous intravenous inotrope therapy
- Presence of a ventricular assist device or previous heart transplant
- Contraindication to cardiac MRI; participants under 12 years unable to complete MRI without sedation may have echocardiograms instead
- Prior organ transplantation
- Started cardiac resynchronization therapy within 6 months before screening
- History of prior gene transfer or cell therapy
- Poorly controlled diabetes with hemoglobin A1c of 8% or higher
- Active blood or solid organ cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
2
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
3
Indiana University - Riley Children's Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
8
Instituto D'or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, Brazil, 41253-190
Actively Recruiting
9
Campinas State University (UNICAMP)
Campinas, São Paulo, Brazil, 13083-887
Actively Recruiting
10
Centre Hospitalier de Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
11
Motol University Hospital and the Second Faculty of Medicine
Prague, Czechia, 15006
Actively Recruiting
12
Institut de Cardiologie Hopital Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
13
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
14
Hospital Univeritario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
Research Team
L
Lexeo Clinical Trials
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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