Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis
NCT ID: NCT06465810
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1850 participants
OBSERVATIONAL
2024-06-25
2031-12-29
Brief Summary
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Detailed Description
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The study plans to enroll a minimum of 1850 patients with ATTR amyloidosis, including a minimum of 850 patients with ATTR cardiomyopathy (ATTR-CM), and a minimum of 100 patients with ATTRv-PN hereditary polyneuropathy.
The enrollment period is expected to last approximately 4 years. The duration of follow-up for each patient will be at least 3 years and up to 7 years depending on the date when the patient is enrolled.
This study design will include both primary and secondary data. Primary data will consist of patient-reported outcome (PRO) questionnaires. Patients will be asked to complete electronic PRO questionnaires at enrollment and every 6 months (±3 months) only during routine visits. Secondary data will consist of demographic, clinical, and treatment information, and will be collected as per routine clinical practice. These data will be abstracted directly from the electronic health record or review of paper charts for each patient and entered in the electronic data capture system. No site visits are required for this study, and patients will not be contacted for data collection outside of routine clinic visits.
For patients enrolled in the United States, a tokenization process (creation of a unique, encrypted identifier called a token, in place of personal identifiable information) will be used to collect additional de-identified data (e.g., healthcare resource use, healthcare costs) from other sources that are part of patients' routine medical care (electronic medical, hospital, or pharmacy records). Only de-identified data will be analyzed. Patients will be given a choice within the informed consent form to opt in or opt out of participating in the tokenization process.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ATTR cardiomyopathy (ATTR-CM)
Patients with ATTR-CM at enrollment
Treatment of transthyretin (ATTR) amyloidosis in observational study setting
Data will be collected on patients with ATTR amyloidosis in a real-world setting
Hereditary polyneuropathy (ATTRv-PN)
Patients with ATTRv-PN at enrollment
Treatment of transthyretin (ATTR) amyloidosis in observational study setting
Data will be collected on patients with ATTR amyloidosis in a real-world setting
ATTR-Mixed
Patients with a mixed ATTR amyloidosis phenotype
Treatment of transthyretin (ATTR) amyloidosis in observational study setting
Data will be collected on patients with ATTR amyloidosis in a real-world setting
Interventions
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Treatment of transthyretin (ATTR) amyloidosis in observational study setting
Data will be collected on patients with ATTR amyloidosis in a real-world setting
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of amyloid transthyretin (ATTR) amyloidosis
* Aged ≥18 years at the time of signing the informed consent
* Patient willing and able to participate in collection of electronic patient reported outcomes (PROs)
Exclusion Criteria
* Involvement in the planning and/or conduct of the current study
* Patients with evidence of primary or light chain amyloidosis (AL) or serum protein A amyloidosis (AA)
* Asymptomatic patients with ATTR amyloidosis and asymptomatic ATTR mutation carriers
18 Years
130 Years
ALL
No
Sponsors
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ICON plc
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
La Jolla, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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New Brunswick, New Jersey, United States
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Manhasset, New York, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Danville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greenville, South Carolina, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Rimouski, Quebec, Canada
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Würzburg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Aachen, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Homburg, Saarland, Germany
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Berlin, , Germany
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Bilbao, Basque Country, Spain
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Salamanca, Castille and León, Spain
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Birmingham, West Midlands, United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
References
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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.
Other Identifiers
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D8450R00003
Identifier Type: -
Identifier Source: org_study_id