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NCT Number: NCT06355934

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

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.

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Key information

Conditions

ATTR Amyloidosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. 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

    Annualized events rate for: Overall outpatient visits

  2. 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

    Annualized events rate for: Overall outpatient visits by specialty

  3. 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

    Annualized events rate for: Emergency department visits

  4. 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

    Annualized events rate for: Hospitalizations (bed days)

  5. 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

    Annualized events rate for: Hospitalizations Overlaps (e.g., hospitalization after emergency department visit) are allowed and counted as separate visits

  6. 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

    This variable will describe all-cause direct medical and pharmacy costs only, utilizing the amount charged, where available in the data. The direct medical costs will include costs incurred from inpatient stays, outpatient visits, emergency room visits, procedures, and laboratory tests. The inclusion of pharmacy costs is subject to data availability and will include all pharmacy costs per patient separated on pharmacy dispensed and in-hospital dispensed when possible. When feasible, costs will be divided on all-cause, CV, and other specialties

  7. 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

    Cardiac transplant (Time to event)

  8. 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

    Mortality (time-to-event)

  9. 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

    Liver transplant (time-to-event)

  10. 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

    Heart failure hospitalization (time-to-event)

  11. 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

    New amyloidosis manifestation (time-to-event); Time to the first development of a new clinical manifestation that the patient did not have pre-index)

  12. 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

    Time to hospitalization (all-cause)

  13. 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

    The NIS Score has a range of 0 to 244 and a higher NIS score indicates poorer function

  14. 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

    The NIS-LL score has a range of 0-88 and a greater NIS-LL score indicates poorer function

  15. 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

    The NIS+7 Score has a range of -26.04 to 270.04 and a higher NIS+7 score indicates poorer function

  16. 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

    The mNIS+7 Score has a range of -22.32 to 102.32 and a higher mNIS+7 score indicates poorer function

  17. 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

    NSC score is a questionnaire composed of 38 questions that assess the presence and severity of these neuropathy symptoms. The NSC score ranges from -114 to 114 for males and -108 to 108 for females. Greater scores indicate worse symptom severity; a negative value indicates an improvement in symptom severity from baseline

  18. 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

    The PND is a 6-stage scoring system: Stage 0: no impairment; Stage 1: sensory disturbances but preserved walking capabilities; Stage 2: impaired walking capacity, but ability to walk without a stick or crutches; Stage 3A/B: walking with help of 1 or 2 sticks or crutches; Stage 4: confined to wheel chair or bedridden. A greater stage indicates greater impairment

  19. 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

    Any other relevant clinical measurement of ATTR amyloidosis functional status

Secondary outcomes

  1. Health Care Resource Utilization (HCRU) - 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.

    Annualized events rate for: Overall outpatient visits

  2. Health Care Resource Utilization (HCRU) - 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.

    Annualized events rate for: Overall outpatient visits by specialty

  3. Health Care Resource Utilization (HCRU) - 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.

    Annualized events rate for: Emergency department visits

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

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

    Annualized events rate for: Hospitalizations (bed days)

  5. Health Care Resource Utilization (HCRU) - Hospitalizations

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

    Annualized events rate for: Hospitalizations Overlaps (e.g., hospitalization after emergency department visit) are allowed and counted as separate visits

  6. Health Care Resource Utilization (HCRU) - Health care cost

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

    This variable will describe all-cause direct medical and pharmacy costs only, utilizing the amount charged, where available in the data. The direct medical costs will include costs incurred from inpatient stays, outpatient visits, emergency room visits, procedures, and laboratory tests. The inclusion of pharmacy costs is subject to data availability and will include all pharmacy costs per patient separated on pharmacy dispensed and in-hospital dispensed when possible. When feasible, costs will be divided on all-cause, CV, and other specialties

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

OverTTuRe: An Observational Multi-Country Study Collecting Real-World Secondary Data on the Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis

Acronym: OverTTuRe

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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