Health Trials

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

ConditionATTR Amyloidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

This study will include data from patients aged \> 18 years with a diagnosis of ATTR amyloidosis or other evidence confirming ATTR amyloidosis. Patients will be followed until exit from the database (loss to follow-up), death, or end of database period (data collection). Baseline data will apply a lookback period of 12 months. Patient identification will be from 2014-01-01 onwards

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • no intervention

    Other intervention

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

Treatment groups

52,121 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ATTR cardiomyopathy1 intervention
Group B: ATTR polyneuropathy1 intervention
Group C: ATTR unknown1 intervention
Group D: ATTR with mixed phenotype1 intervention
Group E: ATTR wild type1 intervention
Group F: ATTR hereditary1 intervention

Trial outcomes

Primary outcomes

1

Health Care Resource Utilization (HCRU) - Outpatient visits

Annualized events rate for: Overall 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
2

Health Care Resource Utilization (HCRU) - Outpatient visits by specialty

Annualized events rate for: Overall 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
3

Health Care Resource Utilization (HCRU) - Emergency department visits

Annualized events rate for: 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
4

Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay

Annualized events rate for: Hospitalizations (bed days)

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

Secondary outcomes

1

Health Care Resource Utilization (HCRU) - Outpatient visits

Annualized events rate for: Overall outpatient visits

Time frame
From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
2

Health Care Resource Utilization (HCRU) - Outpatient visits by specialty

Annualized events rate for: Overall outpatient visits by specialty

Time frame
From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
3

Health Care Resource Utilization (HCRU) - Emergency department visits

Annualized events rate for: Emergency department visits

Time frame
From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
4

Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay

Annualized events rate for: Hospitalizations (bed days)

Time frame
From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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