OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: no intervention.
- Who it may be relevant to
- Registry conditions: ATTR Amyloidosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, China, Denmark, Germany +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other no intervention
not applicable, this is an observational retrospective data analysis study; no interventions in the study
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 11 centers
- Research Site — A Coruña
- Research Site — Barcelona
- Research Site — Bilbao
- Research Site — El Palmar
- Research Site — Huelva
- Research Site — Las Palmas de Gran Canaria
- Research Site — Madrid
- Research Site — Majadahonda
- … and 3 more centers
China · 5 centers
- Research Site — Beijing
- Research Site — Changsha
- Research Site — Chengdu
- Research Site — Guangzhou
- Research Site — Wuhan
Italy · 3 centers
- Research Site — Lecce
- Research Site — Messina
- Research Site — Milan
Portugal · 2 centers
- Research Site — Lisbon
- Research Site — Porto
Sweden · 2 centers
- Research Site — Södertälje
- Research Site — Umeå
United States · 1 center
- Research Site — Eden Prairie
Canada · 1 center
- Research Site — Calgary
Denmark · 1 center
- Research Site — Horsens
Germany · 1 center
- Research Site — Berlin
Japan · 1 center
- Research Site — Tokyo
United Kingdom · 1 center
- Research Site — London
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 PMID 42201638
- Gillmore 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. PMID 40108078
Identifiers
NCT: NCT06355934 · D8450R00004