Recruiting

Observational Study

Sponsor:

Lexeo Therapeutics

Code:

NCT06976606

Conditions

Arrhythmogenic Cardiomyopathy

PKP2-ACM

PKP2-ARVC

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Arrhythmogenic Cardiomyopathy

PKP2-ACM

PKP2-ARVC

Study ID

NCT06976606

Start date

Jan 23, 2024

Status verified date

May, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Premature ventricular contractions (PVC) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Person*: Lexeo Clinical Trials

212-547-9879clinicaltrials@lexeotx.com

Locations

Leland Stanford Junior University

Recruiting

Redwood City, California, United States, 94063-3126

Contacts

Priya Nair

512-217-3812ashas@stanford.edu

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Crystal Tichnell

410-502-7161ctichne1@jhmi.edu

Northshore University Healthsystem Research Institute

Recruiting

Columbia, Maryland, United States, 21044

Contacts

bprindeville@northshore.org

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Muhammad Hussain

734-765-8217muhammhu@med.umich.edu

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

wcabral1@hfhs.org

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

lori_caufield@urmc.rochester.edu

More Information

Sponsor

Lexeo Therapeutics

Last update posted

May 16, 2025

Last verified

May, 2025

Keywords

  • Arrhythmogenic Cardiomyopathy
  • ACM
  • Cardiomyopathy
  • ARVC
  • Arrhythmogenic Right Ventricular
  • Arrhythmogenic Right Ventricular Dysplasia
  • Genetic cardiomyopathy
  • Gene Therapy
  • PKP2 Gene
  • Plakophilin-2
  • LX2020
  • SNAPSHOT-PKP2
  • Ventricular Arrhythmia
  • PVCs
  • Sudden Cardiac Death
  • Cardiac Arrest

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lexeo Therapeutics on 2025-05-16.