OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis

Purpose

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.

Condition

  • ATTR Amyloidosis

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients aged >18 years at study index date AND - A reported diagnosis code for amyloidosis OR - A claim for ATTR-specific treatment OR - A positive biopsy for amyloidosis and positive immunostaining result of biopsy for ATTR

Exclusion Criteria

  • Evidence of primary (AL) and secondary (AA) amyloidosis AND/OR - At least one claim/procedure code for stem cell transplant or at least two claims/procedure codes for chemotherapy and autoimmune disease drugs which may represent AL (primary) or AA (secondary) amyloidosis treatments

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

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.