protocolSection identificationModule nctId: NCT06311708, orgStudyIdInfo id: TN-401-0011, briefTitle: Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), acronym: RIDGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-31, primaryCompletionDateStruct date: 2030-03-29, completionDateStruct date: 2030-07-11, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Tenaya Therapeutics, class: INDUSTRY, collaborators name: University of California, San Francisco, collaborators name: Brigham and Women's Hospital, collaborators name: New York University, collaborators name: University of Colorado, Denver, collaborators name: Johns Hopkins University, collaborators name: The Cleveland Clinic, collaborators name: Mayo Clinic, collaborators name: Medical University of South Carolina, collaborators name: Hopital Louis Pradel, collaborators name: Istituti Clinici Scientifici Maugeri SpA, collaborators name: The Queen Elizabeth Hospital, collaborators name: St George's University Hospitals NHS Foundation Trust, collaborators name: Royal Brompton & Harefield NHS Foundation Trust, collaborators name: Barts & The London NHS Trust, descriptionModule briefSummary: This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy., conditionsModule conditions: Arrhythmogenic Right Ventricular Cardiomyopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Investigate the seroprevalence of pre-existing antibodies to AAV9 in patients with PKP2-associated ARVC, secondaryOutcomes measure: To characterize the burden of illness in patients with pathogenic or likely pathogenic PKP2 mutations, secondaryOutcomes measure: To characterize arrhythmic risk in patients with pathogenic or likely pathogenic PKP2 mutations, secondaryOutcomes measure: To evaluate functional status and Quality of Life (QoL) in patients with pathogenic or likely pathogenic PKP2 mutations, secondaryOutcomes measure: To evaluate heart function as assessed by imaging in patients with pathogenic or likely pathogenic PKP2 mutations, otherOutcomes measure: • To monitor biomarkers associated with disease progression and inflammation in patients with pathogenic or likely pathogenic PKP2 mutations, otherOutcomes measure: To evaluate genetics associated with PKP2-associated ARVC, otherOutcomes measure: To evaluate the effect of other cardiac mutations or other genetic variants that might affect the penetrance and/or expressivity of PKP2 mutations in patients with pathogenic or likely pathogenic PKP2 mutations, otherOutcomes measure: To evaluate health care utilization in patients with pathogenic or likely pathogenic PKP2 mutations, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Vasanth Vedantham, MD, PhD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: University of Colorado, Denver, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Matthew Taylor, MD, PhD, role: CONTACT, geoPoint lat: 39.72943, lon: -104.83192, locations facility: John Hopkins University School of Medicine, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Hugh G Calkins, MD, role: CONTACT, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Neal Lakdawala, MD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Mayo Clinic, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: John Giudicessi, MD PhD, role: CONTACT, geoPoint lat: 44.02163, lon: -92.4699, locations facility: New York University, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: Larry Chinitz, MD, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Wai Hong Wilson Tang, MD, role: CONTACT, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Medical University of South Carolina, status: RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, contacts name: Daniel Judge, MD, role: CONTACT, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Hopital Louis Pradel, status: RECRUITING, city: Bron, country: France, contacts name: Philippe Chevalier, MD, PhD, role: CONTACT, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Istituti Clinici Scientifici Maugeri SpA, status: RECRUITING, city: Pavia, country: Italy, contacts name: Silvia Priori, MD, PhD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: The Queen Elizabeth Hospital, status: RECRUITING, city: Glasgow, zip: G514TF, country: United Kingdom, contacts name: Caroline Coats, MD, role: CONTACT, geoPoint lat: 55.86515, lon: -4.25763, locations facility: Barts & The London Health NHS Trust, status: RECRUITING, city: London, zip: E1 1BB, country: United Kingdom, contacts name: Perry Elliott, MD, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: St. George's University Hospitals NHS Foundation Trust, status: RECRUITING, city: London, zip: SW17 0QT, country: United Kingdom, contacts name: Elijah Behr, MD, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Brompton & Harefield NHS Foundation Trust, status: RECRUITING, city: London, zip: SW3 6NP, country: United Kingdom, contacts name: Antonio Pantazis, MD, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False