Transthyretin Amyloid Cardiomyopathy Clinical Trial
Transthyretin Amyloidosis Outcome Survey (THAOS)
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-type ATTR-CM. It is open-ended with a minimum duration of 10 years. Patients will be followed as long as they are able to participate. The principal aims of this outcome survey are to better understand and characterize the natural history of the disease by studying a large and heterogenous patient population. Survey data may be used to develop new treatment guidelines and recommendations, and to inform and educate clinicians about the management of this disease.
Full Description
n/a NA
Eligibility Criteria
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.
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There are 95 Locations for this study
Birmingham Alabama, 35294, United States
Phoenix Arizona, 85054, United States
Los Angeles California, 90073, United States
Orange California, 92868, United States
San Francisco California, 94117, United States
San Francisco California, 94143, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Deerfield Beach Florida, 33442, United States
Miami Florida, 33136, United States
Plantation Florida, 33324, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60637, United States
Oak Lawn Illinois, 60453, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Bronx New York, 10461, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
Bronx New York, 10467, United States
New York New York, 10016, United States
New York New York, 10034, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43221, United States
Portland Oregon, 97239, United States
McMurray Pennsylvania, 15317, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19140, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15213, United States
Wexford Pennsylvania, 15090, United States
Nashville Tennessee, 37232, United States
Nashville Tennessee, 37232, United States
Salt Lake City Utah, 84132, United States
Milwaukee Wisconsin, 53226, United States
Buenos Aires , 1199A, Argentina
Ciudad Autonoma de Buenos aires , C1428, Argentina
Ciudad Autonoma De Buenos Aires , , Argentina
Leuven , 3000, Belgium
Rio de Janeiro , 21941, Brazil
Sao Paulo , 04012, Brazil
Sofia , 1431, Bulgaria
Calgary Alberta, T2N 4, Canada
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M5G 2, Canada
Nicosia , 23462, Cyprus
Aarhus , 8200, Denmark
Cedex , 94275, France
Colmar , 68024, France
Créteil , 94000, France
Fort De France , 97200, France
Lille , 59037, France
Lille , 59037, France
Toulouse cedex 09 , 31059, France
Aachen , 52074, Germany
Berlin , 13353, Germany
Heidelberg , D-691, Germany
Mainz , 55131, Germany
Mainz , 55131, Germany
Mainz , 55131, Germany
Muenster , 48149, Germany
Holon , 58100, Israel
Ramat Gan , 52621, Israel
Bologna , 40138, Italy
Firenze , 50134, Italy
Messina , 98125, Italy
Messina , 98125, Italy
Pavia , 27100, Italy
Pavia , 27100, Italy
Pisa , 56126, Italy
Roma , 00168, Italy
Matsumoto JP, 390-8, Japan
Chiba , 260-8, Japan
Kumamoto , 860-8, Japan
Seoul , 135-7, Korea, Republic of
Seoul , 143-7, Korea, Republic of
Kuala Lumpur Wilayah Persekutuan, 59100, Malaysia
Distrito Federal , 14000, Mexico
Groningen , 9713 , Netherlands
Guimaraes , 4835-, Portugal
Lisboa , 1649-, Portugal
Lisboa , 1649-, Portugal
Porto , 4099-, Portugal
Bucuresti , 02232, Romania
Riyadh , 11564, Saudi Arabia
Gipuzkoa - SanSebastian Donostia, 20014, Spain
Majadahonda Madrid, 28220, Spain
Barcelona , 08036, Spain
Barcelona , 08907, Spain
Granada , 18013, Spain
Huelva , 21005, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Palma de Mallorca , 07198, Spain
Piteå , 941 5, Sweden
Stockholm , 141 8, Sweden
Umeå , , Sweden
Taipei , 10018, Taiwan
Taipei , 100, Taiwan
Istanbul , 34093, Turkey
Abu Dhabi , , United Arab Emirates
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