RecruitingNCT06976606

A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM

An Observational Study to Assess Real-world Patient Characteristics, Clinical Course, and Treatment Patterns for Symptomatic Patients With Arrhythmogenic Cardiomyopathy (ACM) Due To a PlaKoPhilin-2 Pathogenic Variant (PKP2)

Sponsor

Lexeo Therapeutics

Enrollment

40 participants

Start Date

Jan 23, 2024

Study Type

OBSERVATIONAL

Conditions

Arrhythmogenic Cardiomyopathy PKP2-ACM PKP2-ARVC

Summary

An observational study to assess real-world patient characteristics and clinical course of disease in participants with PKP2-ACM.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria4

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.

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