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

Description

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

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Study Overview

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Study Details

Study overview

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

An Observational Study to Assess Real-world Patient Characteristics, Clinical Course, and Treatment Patterns for Symptomatic Patients With Arrhythmogenic Cardiomyopathy (ACM) Due To a PlaKoPhilin-2 Pathogenic Variant (PKP2)

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

Condition
Arrhythmogenic Cardiomyopathy
Intervention / Treatment

-

Contacts and Locations

Redwood City

Leland Stanford Junior University, Redwood City, California, United States, 94063-3126

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Columbia

Northshore University Healthsystem Research Institute, Columbia, Maryland, United States, 21044

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Rochester

University of Rochester, Rochester, New York, United States, 14642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lexeo Therapeutics,

Lexeo Clinical Trials, STUDY_DIRECTOR, Lexeo Therapeutics

Study Record Dates

2027-09