Status:
COMPLETED
Transthyretin Amyloidosis Outcome Survey (THAOS)
Lead Sponsor:
Pfizer
Conditions:
Transthyretin Gene Mutations
Transthyretin Amyloidosis
Eligibility:
All Genders
18+ years
Brief Summary
THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin amyloidosis (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-typ...
Detailed Description
n/a NA
Eligibility Criteria
Inclusion
- Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion into THAOS:
- Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Males and females greater than or equal to 18 years of age.
- Confirmed genotyped TTR mutation with or without a diagnosis of hereditary or wild-type ATTR amyloidosis. Confirmation of ATTRwt amyloidosis will be determined by genotyped confirmation that patient does not possess a known mutation in TTR gene (ie, is a carrier of wild-type allele only) via genetic testing and one of the following set of criteria (a, b, or c):
- Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by mass spectrometry or immunohistochemistry; or
- Evidence of cardiac involvement by echocardiogram as defined by left ventricle wall thickness of \>12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by mass spectrometry or immunohistochemistry; or
- Evidence of cardiac involvement by echocardiogram as defined by left ventricle wall thickness of \>12 mm, and presence of amyloid in cardiac tissue indirectly confirmed by scintigraphy with a "bone seeking tracer" eg, 99mTC-DPD \[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\], 99mTC- PYP \[Pyrophosphate\], and 99mTC-HMDP \[hydroxymethylene diphosphonate\] with Perugini grade greater than or equal to 2.
- Exclusion Criteria
- Patients meeting any of the following will not be included in the study:
- 1\. Patient has evidence of primary (light chain) or secondary amyloidosis.
Exclusion
Key Trial Info
Start Date :
January 4 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 19 2023
Estimated Enrollment :
6718 Patients enrolled
Trial Details
Trial ID
NCT00628745
Start Date
January 4 2008
End Date
June 19 2023
Last Update
November 22 2024
Active Locations (113)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
3
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
4
University of California, Irvine
Orange, California, United States, 92868