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Home » Clinical Trials » Amyloidosis

Clinical Trial Details

Overview

Research Study Summary

A clinical research study of None. Observational Study. for the treatment of Transthyretin Mutations or Transthyretin Amyloidosis

Research Study Title

Transthyretin-associated Amyloidosis Outcomes Survey (Thaos): A Global, Multi-center, Longitudinal, Observational Survey Of Patients With Documented Transthyretin (Ttr) Mutations Or Wild-type Ttr Amyloidosis

Purpose

THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin-associated amyloidoses (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.

To Learn more
Phase

4

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Pfizer

Duration

162 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Written informed consent.

  • Patient has confirmed: genotyped TTR mutation with or without a diagnosis of TTR-associated amyloidosis (e.g., ATTR-PN, ATTR-CM), or Wild-type TTR-associated amyloidosis with cardiomyopathy (wild-type ATTR-CM).

  • Confirmation of wild-type ATTR-CM will be determined by one of the following set of criteria (A or B):

A. Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by immunohistochemistry and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing; or B. Evidence of cardiac involvement by echocardiogram as defined by mean left ventricle wall thickness of > 12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by immunohistochemistry, and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing.

Exclusion Criteria:

  • Patient has primary or secondary amyloidosis.

Site Locations (71)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85054 Mayo Clinic
United States California Orange 92868 University of California, Irvine
United States California San Francisco 94143 Office of Sponsored Research
United States California San Francisco 94117 University of California - San Francisco, UCSF Department of Neurology
United States Colorado Aurora 80045 UC Denver;Department of Neurology
United States Connecticut New Haven 06510 Yale School of Medicine
United States Illinois Chicago 60611 Clinical Trials Unit
United States Illinois Chicago 60611 Northwestern University
United States Illinois Chicago 60637 University of Chicago Medical Center
United States Illinois Chicago 60637 University of Chicago Medical Center IRB
United States Illinois Oak Lawn 60453 Advocate Christ Medical Center
United States Illinois Oak Lawn 60453 Clinical Research Office
United States Louisiana New Orleans 70121 John Ochsner Heart & Vascular Institute
United States Maryland Baltimore 21205 Johns Hopkins Hospital
United States Maryland Baltimore 21205 Johns Hopkins Hospital 2
United States Maryland Baltimore 21201 University of Maryland
United States Maryland Baltimore 21201 University of Maryland School of Medicine
United States Massachusetts Boston 02215 Harvard Vanguard Medical Associates
United States Michigan Ann Arbor 48109 University of Michigan
United States Minnesota Rochester 55905 Mayo Clinic
United States New York New York 10032 Columbia University Medical Center 1
United States New York New York 10034 Columbia University Medical Center 2
United States New York New York 10034 Columbia University Medical Center 3
United States Ohio Cleveland 44195 Heart Failure and Cardiac Transplantation Medicine,Cleveland Clinic Foundation
United States Ohio Columbus 43210 The Ohio State University College of Medicine
United States Oregon Portland 97201 Oregon Health Sciences University (OHSU)
United States Pennsylvania Philadelphia 19140 Temple University School of Medicine
United States Pennsylvania Philadelphia 19140 Temple University School of Medicine - Admin Office
United States Pennsylvania Philadelphia 19140 Temple University School of Medicine, Departments of Neurology and Pharmacology
United States Pennsylvania Philadelphia 19104 University of Pennsylvania
United States Pennsylvania Philadelphia 19104 University of Pennsylvania, Penn Presbyterian Medical Center
United States Pennsylvania Philadelphia 19104 University of Pennsylvania, Presbyterian Medical Center, Philadelphia Heart Institute
United States Pennsylvania Pittsburgh 15212 Allegheny General Hospital, Allegheny Singer Research Institute, Cardiology Research
United States Pennsylvania Pittsburgh 15212 Office of Sponsored Research
United States Tennessee Nashville 37232 IRB
United States Tennessee Nashville 37232 Vanderbilt University School of Medicine
Argentina Buenos Aires C1428AQK Instituto de Investigaciones Neurológicas Raúl Carrea
Belgium Leuven 3000 Afdeling Klinische Cardiologie, O&N I
Brazil Rio de Janeiro Ilha do Fundao 21941-913 Hospital Universitario Clementino Fraga FilhoRua Rodolpho Paulo Rocco
Denmark Aarhus N 8200 Aarhus University Hospital, Skejby
France Créteil 94000 CHU Henri Mondor
France Fort de France 97200 Hopital Pierre Zobda-Quitman - CHU de Fort de France
France Lille Cedex 59037 Centre National De Reference Maladies Rares Atteintes Vasculaires De La Sclerodermie Systemique
France Paris cedex 10 75475 CHU Henri Mondor-DRCD
France Paris 75013 CHU Henri Mondor- Other
Germany Heidelberg D-69120 Medical University of Heidelberg, Department of Cardiology, Angiology, Respiratory Medicine
Germany Muenster 48149 Universitatsklinikum Muenster - Transplant Hepatology
Italy Bologna 40138 Comitato Etico Indipendente dell Azienda
Italy Firenze 50134 Nefrologia, Dialisi e Medicina dei Trapianti
Italy Messina 98125 AOU Policlinico G. Martino - Messina - Comitato Etico Scientifico
Italy Messina 98125 AOU Policlinico G. Martino - Messina - Dr. Vita
Italy Pavia 27100 Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Pavia - Prof. Merlini
Italy Pavia 27100 Comitato di Bioetica della Fondazione IRCCS Policlinico S. Matteo
Japan JP Matsumoto 390-8621 Shinshu University School of Medicine
Japan Kumamoto 860-8556 Kumamoto University, Department of Diagnostic Medicine
Mexico Tlalpan 14000 Departamento de Neurologia Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Portugal Lisboa 1649-035 Hospital Santa Maria - Centro Estudos Egas Moniz
Portugal Lisboa 1649-035 Hospital Santa Maria - Comissão de Ética
Portugal Lisbon 1649-035 Hospital Santa Maria Servico de Neurologia
Portugal Porto 4099001 Unidade Clinica de Paramiloidose Hospital Geral de Santo Antonio
Spain Spain. Madrid 28007 Hospital Gregorio Marañón
Spain Barcelona 8036 Hospital Clinic Villarroel
Spain Barcelona 8036 Hospital Clinic Villarroel 2
Spain Barcelona 8036 Hospital Clinic Villarroel 3
Spain Barcelona Hospital Universitari de Bellvitge
Spain Donostia-San Sebastian 20012 Hospital Donostia
Spain Majadahonda 28222 Hospital Universitario Puerta de Hierro
Spain Palma de Mallorca 07198 Hospital Son Llatzer
Sweden Piteå 941 50 Piteå Älvdals Hospital
Sweden Umeå Umeå University Hospital
Turkey Istanbul 34093 Istanbul University,Istanbul Faculty of Medicine,Department of Neurology

Contact

Pfizer CT.gov Call Center
1-800-718-1021

NCT ID: NCT00628745

Date Last Changed: March 6, 2015

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