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

Recruiting now

Conditions studied: Arrhythmogenic Cardiomyopathy, PKP2-ACM, PKP2-ARVC

In brief

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

Key facts

Study ID

NCT06976606

Run by

Lexeo Therapeutics

People needed

40

Starts

2024-01-23

Expected to finish

2027-09-01

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Leland Stanford Junior University — Redwood City, California, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Northshore University Healthsystem Research Institute — Columbia, Maryland, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• University of Rochester — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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