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.

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Full Description

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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.

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Estimated Enrollment:

6752

Study ID:

NCT00628745

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 95 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
VA Greater Los Angeles Healthcare System
Los Angeles California, 90073, United States
University of California, Irvine
Orange California, 92868, United States
University of California - San Francisco, UCSF Department of Neurology
San Francisco California, 94117, United States
Office of Sponsored Research
San Francisco California, 94143, United States
Stanford University School of Medicine
Stanford California, 94305, United States
UC Denver
Aurora Colorado, 80045, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven Connecticut, 06510, United States
UHealth Deerfield Beach
Deerfield Beach Florida, 33442, United States
University of Miami Hospital & Clinics
Miami Florida, 33136, United States
UHealth Plantation
Plantation Florida, 33324, United States
Clinical Trials Unit
Chicago Illinois, 60611, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Medical Center IRB
Chicago Illinois, 60637, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Advocate Christ Medical Centre
Oak Lawn Illinois, 60453, United States
John Ochsner Heart & Vascular Institute
New Orleans Louisiana, 70121, United States
University of Maryland School of Medicine
Baltimore Maryland, 21201, United States
University of Maryland
Baltimore Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Harvard Vanguard Medical Associates
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Cardiology Clinic at Montefiore Hutchinson Campus
Bronx New York, 10461, United States
Montefiore Medical Center-Jack D. Weiler Hospital
Bronx New York, 10461, United States
Congestive Heart Failure Clinic
Bronx New York, 10467, United States
Montefiore Moses Division
Bronx New York, 10467, United States
NYU Medical Center
New York New York, 10016, United States
Columbia University Medical Center
New York New York, 10034, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
The Ohio University College of Medicine
Columbus Ohio, 43210, United States
OSU Wexner Medical Center
Columbus Ohio, 43221, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Peters Township Health and Wellness Pavillion
McMurray Pennsylvania, 15317, United States
Penn Presbyterian Medical Center-University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia Pennsylvania, 19104, United States
Temple University School of Medicine
Philadelphia Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Admin
Pittsburgh Pennsylvania, 15213, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh Pennsylvania, 15213, United States
Wexford Health and Wellness Pavillion
Wexford Pennsylvania, 15090, United States
IRB
Nashville Tennessee, 37232, United States
Vanderbilt University School of Medicine
Nashville Tennessee, 37232, United States
The University of Utah Health Sciences Center
Salt Lake City Utah, 84132, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires , 1199A, Argentina
FLENI
Ciudad Autonoma de Buenos aires , C1428, Argentina
Instituto De Investigaciones Medicas Dr Alfredo Lanari
Ciudad Autonoma De Buenos Aires , , Argentina
Afdeling Klinische Cardiologie, O&N I
Leuven , 3000, Belgium
Hospital Universitário Clementino Fraga Filho -HUCFF Universidade Federal do Rio de Janeiro
Rio de Janeiro , 21941, Brazil
Instituto Dante Pazzanese De Cardiologia
Sao Paulo , 04012, Brazil
Alexandrovska University Hospital Clinic of Neurology
Sofia , 1431, Bulgaria
University of Alberta Foothills Medical Centre
Calgary Alberta, T2N 4, Canada
Toronto General Hospital-University Health Network
Toronto Ontario, M5G 2, Canada
Toronto General Hospital
Toronto Ontario, M5G 2, Canada
Cyprus Institute of Neurology and Genetics
Nicosia , 23462, Cyprus
Aarhus University Hospital, Skejby
Aarhus , 8200, Denmark
CHU de Bicetre
Cedex , 94275, France
Hopital Louis Pasteur
Colmar , 68024, France
CHU Henri Mondor
Créteil , 94000, France
Chu De Fort De France
Fort De France , 97200, France
CHRU de Lille, Hopital Claude Huriez
Lille , 59037, France
Hopital Salengro - CHRU de Lille
Lille , 59037, France
CHU de Toulouse - Hopital Rangueil
Toulouse cedex 09 , 31059, France
University Hospital of RWTH Aachen
Aachen , 52074, Germany
Charite CAmpus Rudolf-Virchow-Klinikum
Berlin , 13353, Germany
Medical University of Heidelberg
Heidelberg , D-691, Germany
Johann-Gutenberg-Universität
Mainz , 55131, Germany
University Medical Center, Johannes Gutenberg-University Mainz
Mainz , 55131, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz KöR
Mainz , 55131, Germany
Universitatsklinikum Muenster - Transplant Hepatology
Muenster , 48149, Germany
Wolfson Medical Center
Holon , 58100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Comitato Etico Indipendente dell Azienda
Bologna , 40138, Italy
Azienda Ospedaliero-Universitaria di Careggi
Firenze , 50134, Italy
AOU Policlinico G. Martino - Messina - Comitato Etico Scientifico
Messina , 98125, Italy
AOU Policlinico G. Martino - Messina - Dr. Vita
Messina , 98125, Italy
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Pavia - Prof. Merlini
Pavia , 27100, Italy
Comitato di Bioetica della Fondazione IRCCS Policlinico S. Matteo
Pavia , 27100, Italy
Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica (Ftgm)
Pisa , 56126, Italy
Fondazione Policlinico Gemelli - Universita Cattolica del Sacro Cuore
Roma , 00168, Italy
Shinshu University School of Medicine
Matsumoto JP, 390-8, Japan
Chiba University Hospital
Chiba , 260-8, Japan
Kumamoto University
Kumamoto , 860-8, Japan
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul , 135-7, Korea, Republic of
Konkuk University Medical Center
Seoul , 143-7, Korea, Republic of
University Malaya Medical Centre (UMMC)
Kuala Lumpur Wilayah Persekutuan, 59100, Malaysia
Instituto Nacional de Ciencia Medicas y Nutricion Salvador Zubiran
Distrito Federal , 14000, Mexico
University Medical Center Groningen
Groningen , 9713 , Netherlands
Centro Hospitalar Do Alto Ave, Epe
Guimaraes , 4835-, Portugal
Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria
Lisboa , 1649-, Portugal
Hospital Santa Maria
Lisboa , 1649-, Portugal
Unidade Clinica de Paramiloidose-Centro Hospitalar Porto,EPE-Hospital Geral Santo Antonio
Porto , 4099-, Portugal
Institutul De Cardiologie Prof. Dr. C. C. Iliescu Spitalului Fundeni
Bucuresti , 02232, Romania
King Faisal Specialist Hospital and Research Center
Riyadh , 11564, Saudi Arabia
Hospital Universitario Donostia
Gipuzkoa - SanSebastian Donostia, 20014, Spain
Hospital Universitario Puerta de Hierro
Majadahonda Madrid, 28220, Spain
Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona
Barcelona , 08036, Spain
Hospital Universitari de Bellvitge
Barcelona , 08907, Spain
Hospital de Rehabilitacion y Traumatologia Virgen de las Nieves
Granada , 18013, Spain
Hospital Juan Ramon Jimenez
Huelva , 21005, Spain
Hospital Gregorio Marañón
Madrid , 28007, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Son Llatzer
Palma de Mallorca , 07198, Spain
Piteå Älvdals Hospital
Piteå , 941 5, Sweden
Karolinska University Hospital, Huddinge
Stockholm , 141 8, Sweden
Umeå University Hospital
Umeå , , Sweden
National Taiwan University Hospital
Taipei , 10018, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Istanbul University,Istanbul Faculty of Medicine,Department of Neurology
Istanbul , 34093, Turkey
Cleveland Clinic Abu Dhabi LLC
Abu Dhabi , , United Arab Emirates

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Estimated Enrollment:

6752

Study ID:

NCT00628745

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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