Clinical Trials in the USA / NCT06976606
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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