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NCT06976606Recruiting

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

Lexeo Therapeutics

Start Date

1/23/2024

Completion Date

9/1/2027

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 burden of illness of patients with PKP2-ACM, and to prospectively evaluate changes in key cardiac parameters and patient-reported outcome measures (PROMs) associated with PKP2-ACM progression.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * 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 Criteria: * 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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Conditions

Arrhythmogenic CardiomyopathyPKP2-ACMPKP2-ARVC

Locations

Leland Stanford Junior University

Redwood City, California 94063-3126

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Northshore University Healthsystem Research Institute

Columbia, Maryland 21044

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

University of Rochester

Rochester, New York 14642

United States