protocolSection identificationModule nctId: NCT06355934, orgStudyIdInfo id: D8450R00004, briefTitle: OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis, acronym: OverTTuRe, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-21, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments) in patients with ATTR amyloidosis, and to better understand how the disease is presented., conditionsModule conditions: ATTR Amyloidosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 55000, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Outpatient visits, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Outpatient visits by specialty, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Emergency department visits, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Hospitalizations, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Health care cost, primaryOutcomes measure: Cardiac transplant, primaryOutcomes measure: All cause mortality, primaryOutcomes measure: Liver transplant, primaryOutcomes measure: Heart Failure Hospitalization, primaryOutcomes measure: New ATTR amyloidosis clinical manifestation, primaryOutcomes measure: Hospitalization (any cause), primaryOutcomes measure: Neuropathy Impairment Score (NIS), primaryOutcomes measure: Neuropathy Impairment Score Lower Limbs (NIS-LL), primaryOutcomes measure: Neuropathy Impairment Score +7 (NIS+7), primaryOutcomes measure: Neuropathy Impairment Score modified +7 (mNIS+7), primaryOutcomes measure: Neuropathy symptoms and change (NCS) score, primaryOutcomes measure: PND (Polyneuropathy Disability), primaryOutcomes measure: Other relevant clinical measurement of ATTR amyloidosis functional status, primaryOutcomes measure: Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QoL-DN) Score, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Outpatient visits, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Outpatient visits by specialty, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Emergency department visits, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Hospitalizations, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Health care cost, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: COMPLETED, city: Eden Prairie, state: Minnesota, zip: 55344, country: United States, geoPoint lat: 44.85469, lon: -93.47079, locations facility: Research Site, status: RECRUITING, city: Horsens, country: Denmark, geoPoint lat: 55.86066, lon: 9.85034, locations facility: Research Site, status: COMPLETED, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Research Site, status: RECRUITING, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False