ClinicalTrials.gov record NCT06355934

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationCanada, China, Denmark, Germany, Italy, Japan, Portugal, Spain, Sweden, United Kingdom, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This retrospective, observational cohort study analyzes existing medical and claims records for people with ATTR amyloidosis. It uses data from 2014 onward and follows patients in the dataset until loss to follow-up, death, or the end of the database period. The study will describe patient characteristics, treatment patterns, healthcare resource use and costs, quality-of-life and neuropathy measures, transplants, and mortality, using up to 12 years of data. No new treatments are given as part of this study.

What it is studying. The study is trying to describe the real-world disease journey in ATTR amyloidosis: patient characteristics at and before diagnosis, patterns of care and treatments, healthcare use and costs, and clinical and humanistic outcomes (for example quality of life and neuropathy scores).

What the researchers hope to learn. Generate real-world evidence on pre- and post-diagnosis disease journeys in ATTR amyloidosis; describe baseline characteristics, treatment patterns, and clinical outcomes; quantify healthcare resource use and direct medical and pharmacy costs; document humanistic outcomes such as health-related quality of life and neuropathy impairment.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • no intervention

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a retrospective study using existing medical and administrative records. If a person’s records meet the study criteria, investigators will extract information already recorded about diagnoses, treatments, healthcare visits and costs, clinical measurements (for example neuropathy scores, ADL assessments, HRQoL if available), and outcomes over time (up to about 12 years from diagnosis). No study intervention or new clinical tests are performed as part of the study. Included patients are followed in the data until they leave the database, die, or the database period ends.

How the study is structured. A retrospective, observational multi-country cohort study using existing medical and claims records (data collected from 2014 onward). Researchers will group patients by ATTR type/phenotype and analyze outcomes and resource use up to 12 years after diagnosis. There is no intervention or study-assigned treatment.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Canada, China, Denmark, Germany, Italy, Japan, Portugal, Spain, Sweden, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 21, 2023
Primary completion
Nov 2, 2026 (estimated)
Study completion
Nov 2, 2026 (estimated)
Target enrollment
52121 participants (estimated)
Last updated on registry
Sep 9, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
AstraZeneca

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (29)

  • Research SiteCompleted

    Eden Prairie, Minnesota, 55344 · United States

  • Research SiteCompleted

    Calgary, Alberta, T2P 4K7 · Canada

  • Research SiteCompleted

    Beijing · China

  • Research SiteCompleted

    Changsha · China

  • Research SiteCompleted

    Chengdu · China

  • Research SiteCompleted

    Guangzhou · China

  • Research SiteCompleted

    Wuhan · China

  • Research SiteCompleted

    Horsens · Denmark

  • Research SiteCompleted

    Berlin · Germany

  • Research SiteRecruiting

    Lecce · Italy

Terms used on this page · explanations by MedicalUpdates.ai

baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
stem cell transplant
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
cohort study
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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