Study identifier:D8450R00004
ClinicalTrials.gov identifier:NCT06355934
EudraCT identifier:N/A
CTIS identifier:N/A
OverTTuRe: An Observational Multi-Country Study Collecting Real-World Secondary Data on the Characteristics, Treatment Patterns and Outcomes of Patients with ATTR amyloidosis
ATTR amyloidosis
Phase 4
No
-
All
55000
Observational
n/a - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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.
This retrospective, observational, longitudinal, multi-country cohort study aims to describe characteristics, treatment patterns, and outcomes in ATTR amyloidosis patients. Primary objectives: Describe patient characteristics (for example demographics, family history of ATTR, key comorbidities and humanistic outcomes (e.g. Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments), treatment patterns, and disease outcomes. Characterize and quantify the healthcare resource utilization (HCRU) in ATTR amyloidosis patients who will be followed post-index until the end of follow-up. Secondary objectives: Describe demographics, clinical characteristics and HCRU in ATTR amyloidosis patients prior to diagnosis.
Location
Status
Location
Tokyo, Japan
Status
Completed
Location
Eden Prairie, Minnesota, United States, 55344
Status
Completed
Location
London, United Kingdom
Status
Completed
Location
Horsens, Denmark
Status
Recruiting
Location
Umea, Sweden
Status
Recruiting
Location
Sodertalje, Sweden
Status
Completed
Location
El Palmar, Spain
Status
Completed
Location
Madrid, Spain
Status
Completed
Arms | Assigned Interventions |
---|---|
ATTR cardiomyopathy Patients with Transthyretin Amyloidosis Cardiomyopathy | Other: no intervention not applicable, this is an observational retrospective data analysis study; no interventions in the study |
ATTR polyneuropathy Patients with Transthyretin Amyloidosis Neuropathy | Other: no intervention not applicable, this is an observational retrospective data analysis study; no interventions in the study |
ATTR unknown Patients with ATTR unknown genotype | Other: no intervention not applicable, this is an observational retrospective data analysis study; no interventions in the study |
ATTR with mixed phenotype Patients with ATTR mixed phenotype | Other: no intervention not applicable, this is an observational retrospective data analysis study; no interventions in the study |
ATTR wild type Patients with Transthyretin Amyloidosis wild type | Other: no intervention not applicable, this is an observational retrospective data analysis study; no interventions in the study |
ATTR hereditary Patients with Transthyretin Hereditary | Other: no intervention not applicable, this is an observational retrospective data analysis study; no interventions in the study |
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