Recruiting

Observational Study

Sponsor:

AstraZeneca

Code:

NCT06355934

Conditions

ATTR Amyloidosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

no intervention

Study Details

Brief summary:

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.

Conditions

ATTR Amyloidosis

Study ID

NCT06355934

Start date

Aug 21, 2023

Status verified date

May, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

52121 participants

Anticipated

Interventions and Outcome Measures

Arms

ATTR cardiomyopathy

Patients with Transthyretin Amyloidosis Cardiomyopathy

ATTR polyneuropathy

Patients with Transthyretin Amyloidosis Neuropathy

ATTR unknown

Patients with ATTR unknown genotype

ATTR with mixed phenotype

Patients with ATTR mixed phenotype

ATTR wild type

Patients with Transthyretin Amyloidosis wild type

ATTR hereditary

Patients with Transthyretin Hereditary

Interventions

no intervention

not applicable, this is an observational retrospective data analysis study; no interventions in the study

Primary outcome measure

  • Health Care Resource Utilization (HCRU) - Outpatient visits [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Health Care Resource Utilization (HCRU) - Outpatient visits by specialty [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Health Care Resource Utilization (HCRU) - Emergency department visits [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Health Care Resource Utilization (HCRU) - Hospitalizations [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Health Care Resource Utilization (HCRU) - Health care cost [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Cardiac transplant [ Time Frame: From diagnosis of ATTR amyloidosis (index date) until date of first cardiac transplant, assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • All cause mortality [ Time Frame: From diagnosis of ATTR amyloidosis (index date) until date of death due to any cause, assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Liver transplant [ Time Frame: From diagnosis of ATTR amyloidosis (index date) until date of first liver transplant, assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Heart Failure Hospitalization [ Time Frame: From diagnosis of ATTR amyloidosis (index date) until date of first hospitalization for heart failure, assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • New ATTR amyloidosis clinical manifestation [ Time Frame: From diagnosis of ATTR amyloidosis (index date) until date of first diagnosis of new ATTR amyloidosis clinical manifestation, assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Hospitalization (any cause) [ Time Frame: From diagnosis of ATTR amyloidosis (index date) until date of first hospitalization for any reason, assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Neuropathy Impairment Score (NIS) [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Neuropathy Impairment Score Lower Limbs (NIS-LL) [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Neuropathy Impairment Score +7 (NIS+7) [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Neuropathy Impairment Score modified +7 (mNIS+7) [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Neuropathy symptoms and change (NCS) score [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • PND (Polyneuropathy Disability) [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]
  • Other relevant clinical measurement of ATTR amyloidosis functional status [ Time Frame: From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Calgary, Alberta, Canada, T2P 4K7

More Information

Sponsor

AstraZeneca

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • ATTR-CM, ATTRv-PN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-05-19.