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Recruiting Observational

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

NCT06976606 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2024-01-23
Last updated
2025-05-16

Condition(s) studied

Arrhythmogenic CardiomyopathyPKP2-ACMPKP2-ARVC

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Premature ventricular contractions (PVC) — 12 months
    Change from baseline

Trial sites (6)

FacilityCityRegionStatus
Leland Stanford Junior University Redwood City California Recruiting
Johns Hopkins University Baltimore Maryland Recruiting
Northshore University Healthsystem Research Institute Columbia Maryland Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
University of Rochester Rochester New York Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06976606 on ClinicalTrials.gov ↗ ← All trials in the USA