Observational Study for PKP2-ACM

This is an observational study looking at people with a specific type of heart condition called PKP2-Arrhythmogenic Cardiomyopathy (PKP2-ACM). Researchers want to understand the real-world characteristics and how the disease progresses over time. You might be able to join if you are an adult between 18 and 65 years old, have a diagnosis of ACM, and a specific genetic change (pathogenic or likely pathogenic truncating variant in PKP2). You also need to have frequent irregular heartbeats (premature ventricular contractions or PVCs) and an implanted heart device (ICD). The study will measure the number of PVCs you have after 12 months to see how the disease is affecting your heart. The current recruitment status is unclear.

Study design
This is an observational study with an unspecified phase, meaning there are no interventions being tested. It involves reviewing past medical records and a prospective (forward-looking) observational period.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, premature ventricular contractions (PVC), is measured at 12 months.

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NCT06976606

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

Recruiting
Not specifiedAges 18–65Observational
Lexeo Therapeutics
~40 participants
Updated 2025-05-16 on ClinicalTrials.gov

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Premature ventricular contractions (PVC)
Measured over 12 months
Arrhythmogenic Cardiomyopathy
PKP2-ACM
PKP2-ARVC
6 sites across 4 states
Maryland2
Michigan2
California1
New York1
  • Lexeo Clinical Trials · STUDY_DIRECTOR · Lexeo Therapeutics

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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.
  • Premature ventricular contractions (PVC)12 months

    Change from baseline