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

AstraZeneca

Status: Enrolling

Conditions: ATTR Amyloidosis

Treatments: Other: no intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06355934

D8450R00004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

55,000 participants in 6 patient groups

ATTR cardiomyopathy

Description:

Patients with Transthyretin Amyloidosis Cardiomyopathy

Treatment:

Other: no intervention

ATTR polyneuropathy

Description:

Patients with Transthyretin Amyloidosis Neuropathy

Treatment:

Other: no intervention

ATTR unknown

Description:

Patients with ATTR unknown genotype

Treatment:

Other: no intervention

ATTR with mixed phenotype

Description:

Patients with ATTR mixed phenotype

Treatment:

Other: no intervention

ATTR wild type

Description:

Patients with Transthyretin Amyloidosis wild type

Treatment:

Other: no intervention

ATTR hereditary

Description:

Patients with Transthyretin Hereditary

Treatment:

Other: no intervention