ATTR AmyloidosisOverTTuReNCT06355934
OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis
An observational study of ATTR Amyloidosis, run by AstraZeneca at 29 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ATTR Amyloidosis
- How many people
- 52,121 participants
- Where
- 29 sitesin 11 countries
- Study dates
- 21 Aug 2023to 2 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
29 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
29 sites in 11 countries
Spain11 sites
- Completed
Research Site
A Coruña
- Completed
Research Site
Barcelona
- Completed
Research Site
Bilbao
- Completed
Research Site
El Palmar
- Completed
Research Site
Huelva
- Completed
Research Site
Las Palmas de Gran Canaria
- Completed
Research Site
Madrid
- Completed
Research Site
Majadahonda
- Completed
Research Site
Palma de Mallorca
- Completed
Research Site
Salamanca
- Completed
Research Site
Valencia
China5 sites
- Completed
Research Site
Beijing
- Completed
Research Site
Changsha
- Completed
Research Site
Chengdu
- Completed
Research Site
Guangzhou
- Completed
Research Site
Wuhan
Italy3 sites, 3 recruiting
- Recruiting
Research Site
Lecce
- Recruiting
Research Site
Messina
- Recruiting
Research Site
Milan
Portugal2 sites, 2 recruiting
- Recruiting
Research Site
Lisbon
- Recruiting
Research Site
Porto
United States1 site
- Completed
Research Site
Eden Prairie, Minnesota, 55344
About this study
Official title: OverTTuRe: An Observational Multi-Country Study Collecting Real-World Secondary Data on the 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.
Read the 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.
- Conditions
- ATTR Amyloidosis
- Being tested
- no intervention
- Keywords
- ATTR-CM, ATTRv-PN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
not applicable, this is an observational retrospective data analysis study; no interventions in the study
| Study group | Role | What they receive |
|---|---|---|
| ATTR cardiomyopathy | Patients with Transthyretin Amyloidosis Cardiomyopathy Receives: Other: no intervention | |
| ATTR polyneuropathy | Patients with Transthyretin Amyloidosis Neuropathy Receives: Other: no intervention | |
| ATTR unknown | Patients with ATTR unknown genotype Receives: Other: no intervention | |
| ATTR with mixed phenotype | Patients with ATTR mixed phenotype Receives: Other: no intervention | |
| ATTR wild type | Patients with Transthyretin Amyloidosis wild type Receives: Other: no intervention | |
| ATTR hereditary | Patients with Transthyretin Hereditary Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Care Resource Utilization (HCRU) - Outpatient visits
Annualized events rate for: Overall outpatient visits
Measured: 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
Annualized events rate for: Overall outpatient visits by specialty
Measured: 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
Annualized events rate for: Emergency department visits
Measured: 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
Annualized events rate for: Hospitalizations (bed days)
Measured: 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
Annualized events rate for: Hospitalizations Overlaps (e.g., hospitalization after emergency department visit) are allowed and counted as separate visits
Measured: 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
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
Measured: 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
Cardiac transplant (Time to event)
Measured: 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
Mortality (time-to-event)
Measured: 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
Liver transplant (time-to-event)
Measured: 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
Heart failure hospitalization (time-to-event)
Measured: 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
New amyloidosis manifestation (time-to-event); Time to the first development of a new clinical manifestation that the patient did not have pre-index)
Measured: 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 to hospitalization (all-cause)
Measured: 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)
The NIS Score has a range of 0 to 244 and a higher NIS score indicates poorer function
Measured: 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)
The NIS-LL score has a range of 0-88 and a greater NIS-LL score indicates poorer function
Measured: 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)
The NIS+7 Score has a range of -26.04 to 270.04 and a higher NIS+7 score indicates poorer function
Measured: 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)
The mNIS+7 Score has a range of -22.32 to 102.32 and a higher mNIS+7 score indicates poorer function
Measured: 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
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
Measured: 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)
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
Measured: 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
Any other relevant clinical measurement of ATTR amyloidosis functional status
Measured: 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 (6)
Health Care Resource Utilization (HCRU) - Outpatient visits
Annualized events rate for: Overall outpatient visits
Measured: From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
Health Care Resource Utilization (HCRU) - Outpatient visits by specialty
Annualized events rate for: Overall outpatient visits by specialty
Measured: From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
Health Care Resource Utilization (HCRU) - Emergency department visits
Annualized events rate for: Emergency department visits
Measured: From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay
Annualized events rate for: Hospitalizations (bed days)
Measured: From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
Health Care Resource Utilization (HCRU) - Hospitalizations
Annualized events rate for: Hospitalizations Overlaps (e.g., hospitalization after emergency department visit) are allowed and counted as separate visits
Measured: From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
Health Care Resource Utilization (HCRU) - Health care cost
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
Measured: From up to 12 years prior to ATTR amyloidosis diagnosis, assessed throughout the study, up to a maximum of 12 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start21 Aug 2023
- Primary completion2 Nov 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ATTR AmyloidosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52,121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355934
- Sponsor's protocol ID
- D8450R00004
- Acronym
- OverTTuRe
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Alexander KM, Kohsaka S, Poulsen SH, Terkelsen AJ, Smith JG, Sundstrom J, Wright J, Jarbrink K, Bhimjiyani AG, Davis L, Matsue Y, Anderson LJ, Pilebro B. Contemporary Description of Clinical Characteristics and Outcomes in Patients with Hereditary ATTR Amyloidosis: Results from the Multicountry OverTTuRe Study. Cardiol Ther. 2026 Jun;15(2):201-229. doi: 10.1007/s40119-026-00450-y. Epub 2026 May 27.
PubMed 42201638Gillmore JD, Hahn K, Smith JG, Conceicao I, Tian Z, Grogan M, Pao C, Wittbrodt E, Jarbrink K, Papas MA, Davis MK. Rationale and Design of ANTHOLOGY: An ATTR Amyloidosis Real-World Evidence Program Aiming to Address Gaps in Amyloidosis Care. Cardiol Ther. 2025 Sep;14(3):477-490. doi: 10.1007/s40119-025-00402-y. Epub 2025 Mar 19.
PubMed 40108078
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OverTTuRe: An Observational Multi-Country Study Collecting Real-World Secondary Data on the Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis
- ClinicalTrials.gov ID
- NCT06355934
- Acronym / sponsor ID
- OverTTuRe / D8450R00004
- Conditions
- ATTR Amyloidosis
- Keywords
- ATTR-CM, ATTRv-PN
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52,121 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ATTR cardiomyopathy | – | Other: no interventionPatients with Transthyretin Amyloidosis Cardiomyopathy |
| ATTR polyneuropathy | – | Other: no interventionPatients with Transthyretin Amyloidosis Neuropathy |
| ATTR unknown | – | Other: no interventionPatients with ATTR unknown genotype |
| ATTR with mixed phenotype | – | Other: no interventionPatients with ATTR mixed phenotype |
| ATTR wild type | – | Other: no interventionPatients with Transthyretin Amyloidosis wild type |
| ATTR hereditary | – | Other: no interventionPatients with Transthyretin Hereditary |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionnot applicable, this is an observational retrospective data analysis study; no interventions in the study | Other | ATTR cardiomyopathy, ATTR hereditary, ATTR polyneuropathy, ATTR unknown, ATTR wild type, ATTR with mixed phenotype |
Primary outcome
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
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
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
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)
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
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
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 42201638Alexander KM, Kohsaka S, Poulsen SH, Terkelsen AJ, Smith JG, Sundstrom J, Wright J, Jarbrink K, Bhimjiyani AG, Davis L, Matsue Y, Anderson LJ, Pilebro B. Contemporary Description of Clinical Characteristics and Outcomes in Patients with Hereditary ATTR Amyloidosis: Results from the Multicountry OverTTuRe Study. Cardiol Ther. 2026 Jun;15(2):201-229. doi: 10.1007/s40119-026-00450-y. Epub 2026 May 27.
- Derived from this study: PubMed 40108078Gillmore JD, Hahn K, Smith JG, Conceicao I, Tian Z, Grogan M, Pao C, Wittbrodt E, Jarbrink K, Papas MA, Davis MK. Rationale and Design of ANTHOLOGY: An ATTR Amyloidosis Real-World Evidence Program Aiming to Address Gaps in Amyloidosis Care. Cardiol Ther. 2025 Sep;14(3):477-490. doi: 10.1007/s40119-025-00402-y. Epub 2025 Mar 19.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
29 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ATTR Amyloidosis, run by AstraZeneca at 29 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain, China, Italy, Portugal, Sweden and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355934, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.