A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorLexeo Therapeutics
About this trial
An observational study to assess real-world patient characteristics and clinical course of disease in participants with PKP2-ACM.
Eligibility criteria
Qualifiers
Adults with a clinical diagnosis of ACM as defined by the 2010 revised Task Force Criteria (TFC)
Documentation of a pathogenic or likely pathogenic truncating variant in PKP2
Frequent premature ventricular contractions (PVCs)
Patients must have an ICD placed prior to enrollment
Disqualifiers
Evidence of variant(s) in addition to PKP2 that meet standard criteria to be considered pathogenic or likely pathogenic for an arrhythmogenic cardiomyopathy.
A history of other cardiac abnormalities as specified in the protocol.
New York Heart Association symptoms of heart failure of Class IV at the time of consent.
A history of prior gene transfer therapy.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Locations
6Leland Stanford Junior University94063-3126, Redwood CityCalifornia, United States
Johns Hopkins University21287, BaltimoreMaryland, United States
Northshore University Healthsystem Research Institute21044, ColumbiaMaryland, United States
University of Michigan48109, Ann ArborMichigan, United States
Sponsors and collaborators
Lexeo Therapeutics
Lead sponsor
Source ClinicalTrials.gov