RECRUITING

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

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Conditions

Arrhythmogenic CardiomyopathyPKP2-ACMPKP2-ARVCACMCardiomyopathyARVCArrhythmogenic Right VentricularArrhythmogenic Right Ventricular DysplasiaGenetic cardiomyopathyGene TherapyPKP2 GenePlakophilin-2LX2020SNAPSHOT-PKP2Ventricular ArrhythmiaPVCsSudden Cardiac DeathCardiac Arrest

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2024-01-23
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06976606

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults with a clinical diagnosis of ACM as defined by the 2010 revised Task Force Criteria (TFC)
  2. * Documentation of a pathogenic or likely pathogenic truncating variant in PKP2
  3. * Frequent premature ventricular contractions (PVCs)
  4. * Patients must have an ICD placed prior to enrollment
  5. * Left ventricular ejection fraction (LVEF) ≥ 50% for Part A participants. Left ventricular ejection fraction (LVEF) ≥40% for Part B participants.
  1. * Evidence of variant(s) in addition to PKP2 that meet standard criteria to be considered pathogenic or likely pathogenic for an arrhythmogenic cardiomyopathy.
  2. * A history of other cardiac abnormalities as specified in the protocol.
  3. * New York Heart Association symptoms of heart failure of Class IV at the time of consent.
  4. * A history of prior gene transfer therapy.

Contacts and Locations

Study Contact

Person*: Lexeo Clinical Trials
CONTACT
212-547-9879
clinicaltrials@lexeotx.com

Principal Investigator

Lexeo Clinical Trials
STUDY_DIRECTOR
Lexeo Therapeutics

Study Locations (Sites)

Leland Stanford Junior University
Redwood City, California, 94063-3126
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Northshore University Healthsystem Research Institute
Columbia, Maryland, 21044
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Rochester
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: Lexeo Therapeutics

  • Lexeo Clinical Trials, STUDY_DIRECTOR, Lexeo Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-23
Study Completion Date2027-09

Study Record Updates

Study Start Date2024-01-23
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Arrhythmogenic Cardiomyopathy
  • PKP2-ACM
  • PKP2-ARVC