Status:
RECRUITING
A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM
Lead Sponsor:
Lexeo Therapeutics
Conditions:
Arrhythmogenic Cardiomyopathy
PKP2-ACM
Eligibility:
All Genders
18-65 years
Brief Summary
An observational study to assess real-world patient characteristics and clinical course of disease in participants with PKP2-ACM.
Detailed Description
SNAPSHOT-PKP2 is an observational, multicenter study that consists of 2 parts, a retrospective EMR review (up to 2 years) and a prospective observational study (1 year), to evaluate the clinical burde...
Eligibility Criteria
Inclusion
- 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
- Left ventricular ejection fraction (LVEF) ≥ 50% for Part A participants. Left ventricular ejection fraction (LVEF) ≥40% for Part B participants.
Exclusion
- 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.
Key Trial Info
Start Date :
January 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06976606
Start Date
January 23 2024
End Date
September 1 2027
Last Update
May 16 2025
Active Locations (6)
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1
Leland Stanford Junior University
Redwood City, California, United States, 94063-3126
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Northshore University Healthsystem Research Institute
Columbia, Maryland, United States, 21044
4
University of Michigan
Ann Arbor, Michigan, United States, 48109