Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT06976606

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

Led by Lexeo Therapeutics · Updated on 2025-05-16

40

Participants Needed

6

Research Sites

188 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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) 60 50% for Part A participants
  • Left ventricular ejection fraction (LVEF) 50% for Part B participants
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Leland Stanford Junior University

Redwood City, California, United States, 94063-3126

Actively Recruiting

2

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

3

Northshore University Healthsystem Research Institute

Columbia, Maryland, United States, 21044

Actively Recruiting

4

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

5

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

6

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

P

Person*: Lexeo Clinical Trials

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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