Transthyretin Amyloidosis Outcome Survey (THAOS)
THAOS
3 other identifiers
observational
6,718
25 countries
113
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2008
Longer than P75 for all trials
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2008
CompletedFirst Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2023
CompletedResults Posted
Study results publicly available
November 22, 2024
CompletedNovember 22, 2024
October 1, 2024
15.5 years
February 25, 2008
April 4, 2024
October 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who administered a medicinal product without regard to possibility of causal relationship with the study treatment. SAE was defined as one of the following: resulted in death; was life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); constituted a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs.
From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years)
Number of Participants With Treatment Emergent Treatment Related AEs and SAEs
A treatment-related AE was any untoward medical occurrence attributed to the administered medicinal product in a participant who received study drug. Treatment emergent AEs included both SAEs and all non-SAEs. A treatment-related SAE was a treatment-related AE and was defined as any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); constituted a congenital anomaly/birth defect. Causality was assessed by the investigator.
From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years)
Number of All-Cause Deaths
Number of deaths due to any cause was analyzed as time from enrollment or first treatment of tafamidis.
From the start of data collection at Baseline (Day 1) to the end of data collection (Up to 14.4 years)
Secondary Outcomes (23)
Number of Participants With Modified Polyneuropathy Disability (mPND) Scores at Baseline
At the start of data collection at Baseline (Day 1)
Number of Participants With Coutinho Disease Stages at Baseline
At the start of data collection at Baseline (Day 1)
Number of Participants With Karnofsky Performance Index at Baseline
At the start of data collection at Baseline (Day 1)
Number of Participants With Heart Failure at Baseline
At the start of data collection at Baseline (Day 1)
Number of Participants With New York Heart Association (NYHA) Classifications at Baseline
At the start of data collection at Baseline (Day 1)
- +18 more secondary outcomes
Study Arms (1)
Observational
Interventions
Eligibility Criteria
The study population includes patients with confirmed hereditary or wild-type ATTR amyloidosis (inclusive of ATTR-PN and ATTR-CM) and those with TTR gene mutations without a diagnosis of ATTR amyloidosis.
You may qualify if:
- 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.
You may not qualify if:
- Patients meeting any of the following will not be included in the study:
- \. Patient has evidence of primary (light chain) or secondary amyloidosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (113)
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, 94305-5406, 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
St Louis, Missouri, 63110, United States
NYU Medical Center
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10034, United States
Cardiology Clinic at Montefiore Hutchinson Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Jack D. Weiler Hospital
The Bronx, New York, 10461, United States
Congestive Heart Failure Clinic
The Bronx, New York, 10467, United States
Montefiore Moses Division
The Bronx, New York, 10467, 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, 1199ABB, Argentina
FLENI
Buenos Aires, C1428AQK, Argentina
Instituto De Investigaciones Medicas Dr Alfredo Lanari
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, 21941-913, Brazil
Instituto Dante Pazzanese De Cardiologia
São Paulo, 04012-909, Brazil
Alexandrovska University Hospital Clinic of Neurology
Sofia, 1431, Bulgaria
University of Alberta Foothills Medical Centre
Calgary, Alberta, T2N 4Z6, Canada
Toronto General Hospital-University Health Network
Toronto, Ontario, M5G 2C4, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, 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, 31059, France
University Hospital of RWTH Aachen
Aachen, 52074, Germany
Charite CAmpus Rudolf-Virchow-Klinikum
Berlin, 13353, Germany
Medical University of Heidelberg
Heidelberg, D-69120, 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
Münster, 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
Florence, 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, 390-8621, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Kumamoto University
Kumamoto, 860-8556, Japan
University Malaya Medical Centre (UMMC)
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Instituto Nacional de Ciencia Medicas y Nutricion Salvador Zubiran
Distrito Federal, 14000, Mexico
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Centro Hospitalar Do Alto Ave, Epe
Guimarães, 4835-004, Portugal
Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Hospital Santa Maria
Lisbon, 1649-035, Portugal
Unidade Clinica de Paramiloidose-Centro Hospitalar Porto,EPE-Hospital Geral Santo Antonio
Porto, 4099-001, Portugal
Institutul De Cardiologie Prof. Dr. C. C. Iliescu Spitalului Fundeni
Bucharest, 022328, Romania
King Faisal Specialist Hospital and Research Center
Riyadh, 11564, Saudi Arabia
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710, South Korea
Konkuk University Medical Center
Seoul, 143-729, South Korea
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 Llàtzer
Palma de Mallorca, 07198, Spain
Piteå Älvdals Hospital
Piteå, 941 50, Sweden
Karolinska University Hospital, Huddinge
Stockholm, 141 86, 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 (Türkiye)
Cleveland Clinic Abu Dhabi LLC
Abu Dhabi, United Arab Emirates
Related Publications (26)
Wixner J, Dispenzieri A, Amass L, Carlsson M, Riley S, Powers E, Kelly JW. A real-world study of tafamidis in people with transthyretin amyloid cardiomyopathy (ATTR-CM) with heart and nerve symptoms: a plain language summary. Future Cardiol. 2025 Nov 25:1-13. doi: 10.1080/14796678.2025.2583805. Online ahead of print.
PMID: 41292260DERIVEDWixner J, Dispenzieri A, Amass L, Carlsson M, Riley S, Powers E, Kelly JW; THAOS investigators. Survival in a Contemporary, Real-World Cohort of Patients with Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy Treated with Tafamidis: An Analysis from THAOS. Cardiol Ther. 2025 Dec;14(4):583-599. doi: 10.1007/s40119-025-00421-9. Epub 2025 Jul 9.
PMID: 40632476DERIVEDMora-Ayestaran N, Dispenzieri A, Kristen AV, Maurer MS, Diemberger I, Drachman BM, Grogan M, Gupta P, Glass O, Amass L, Garcia-Pavia P; THAOS Investigators. Age- and Sex-Related Differences in Patients With Wild-Type Transthyretin Amyloidosis: Insights From THAOS. JACC Adv. 2024 Jul 12;3(8):101086. doi: 10.1016/j.jacadv.2024.101086. eCollection 2024 Aug.
PMID: 39105117DERIVEDGarcia-Pavia P, Kristen AV, Drachman B, Carlsson M, Amass L, Angeli FS, Maurer MS; THAOS investigators. Survival in a Real-World Cohort of Patients With Transthyretin Amyloid Cardiomyopathy Treated With Tafamidis: An Analysis From the Transthyretin Amyloidosis Outcomes Survey (THAOS). J Card Fail. 2025 Mar;31(3):525-533. doi: 10.1016/j.cardfail.2024.06.003. Epub 2024 Jun 21.
PMID: 38909877DERIVEDGentile L, Diemberger I, Plante-Bordeneuve V, Mazzeo A, Dori A, Luigetti M, Di Paolantonio A, Dispenzieri A, Grogan M, Waddington Cruz M, Adams D, Inamo J, Kristen AV, Lino Cirami C, Chapman D, Gupta P, Glass O, Amass L. Phenotypic characteristics of F64L, I68L, I107V, and S77Y ATTRv genotypes from the Transthyretin Amyloidosis Outcomes Survey (THAOS). PLoS One. 2024 Jan 19;19(1):e0292435. doi: 10.1371/journal.pone.0292435. eCollection 2024.
PMID: 38241252DERIVEDGonzalez-Moreno J, Dispenzieri A, Grogan M, Coelho T, Tournev I, Waddington-Cruz M, Wixner J, Diemberger I, Garcia-Pavia P, Chapman D, Gupta P, Glass O, Amass L; THAOS investigators. Clinical and Genotype Characteristics and Symptom Migration in Patients With Mixed Phenotype Transthyretin Amyloidosis from the Transthyretin Amyloidosis Outcomes Survey. Cardiol Ther. 2024 Mar;13(1):117-135. doi: 10.1007/s40119-023-00344-3. Epub 2023 Dec 20.
PMID: 38117424DERIVEDGentile L, Coelho T, Dispenzieri A, Conceicao I, Waddington-Cruz M, Kristen A, Wixner J, Diemberger I, Gonzalez-Moreno J, Cariou E, Maurer MS, Plante-Bordeneuve V, Garcia-Pavia P, Tournev I, Gonzalez-Costello J, Duarte AG, Grogan M, Mazzeo A, Chapman D, Gupta P, Glass O, Amass L; THAOS investigators. A 15-year consolidated overview of data in over 6000 patients from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Orphanet J Rare Dis. 2023 Nov 10;18(1):350. doi: 10.1186/s13023-023-02962-5.
PMID: 37946256DERIVEDCoelho T, Conceicao I, Waddington-Cruz M, Keohane D, Sultan MB, Chapman D, Amass L; THAOS investigators. A natural history analysis of asymptomatic TTR gene carriers as they develop symptomatic transthyretin amyloidosis in the Transthyretin Amyloidosis Outcomes Survey (THAOS). Amyloid. 2022 Dec;29(4):228-236. doi: 10.1080/13506129.2022.2070470. Epub 2022 Jun 22.
PMID: 35730447DERIVEDDispenzieri A, Coelho T, Conceicao I, Waddington-Cruz M, Wixner J, Kristen AV, Rapezzi C, Plante-Bordeneuve V, Gonzalez-Moreno J, Maurer MS, Grogan M, Chapman D, Amass L; THAOS investigators. Clinical and genetic profile of patients enrolled in the Transthyretin Amyloidosis Outcomes Survey (THAOS): 14-year update. Orphanet J Rare Dis. 2022 Jun 18;17(1):236. doi: 10.1186/s13023-022-02359-w.
PMID: 35717381DERIVEDCampbell CM, LoRusso S, Dispenzieri A, Kristen AV, Maurer MS, Rapezzi C, Lairez O, Drachman B, Garcia-Pavia P, Grogan M, Chapman D, Amass L; THAOS investigators. Sex Differences in Wild-Type Transthyretin Amyloidosis: An Analysis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Cardiol Ther. 2022 Sep;11(3):393-405. doi: 10.1007/s40119-022-00265-7. Epub 2022 May 18.
PMID: 35583798DERIVEDBarroso FA, Coelho T, Dispenzieri A, Conceicao I, Waddington-Cruz M, Wixner J, Maurer MS, Rapezzi C, Plante-Bordeneuve V, Kristen AV, Gonzalez-Duarte A, Chapman D, Stewart M, Amass L; THAOS investigators. Characteristics of patients with autonomic dysfunction in the Transthyretin Amyloidosis Outcomes Survey (THAOS). Amyloid. 2022 Sep;29(3):175-183. doi: 10.1080/13506129.2022.2043270. Epub 2022 Apr 22.
PMID: 35451899DERIVEDNativi-Nicolau J, Siu A, Dispenzieri A, Maurer MS, Rapezzi C, Kristen AV, Garcia-Pavia P, LoRusso S, Waddington-Cruz M, Lairez O, Witteles R, Chapman D, Amass L, Grogan M; THAOS Investigators. Temporal Trends of Wild-Type Transthyretin Amyloid Cardiomyopathy in the Transthyretin Amyloidosis Outcomes Survey. JACC CardioOncol. 2021 Oct 19;3(4):537-546. doi: 10.1016/j.jaccao.2021.08.009. eCollection 2021 Oct.
PMID: 34729526DERIVEDGonzalez-Moreno J, Losada-Lopez I, Cisneros-Barroso E, Garcia-Pavia P, Gonzalez-Costello J, Munoz-Beamud F, Campistol JM, Fernandez-Torron R, Chapman D, Amass L. A Descriptive Analysis of ATTR Amyloidosis in Spain from the Transthyretin Amyloidosis Outcomes Survey. Neurol Ther. 2021 Dec;10(2):833-845. doi: 10.1007/s40120-021-00267-y. Epub 2021 Jul 30.
PMID: 34331265DERIVEDGentile L, Tournev I, Amass L, Chapman D, Mazzeo A; THAOS investigators. Phenotypic Differences of Glu89Gln Genotype in ATTR Amyloidosis From Endemic Loci: Update From THAOS. Cardiol Ther. 2021 Dec;10(2):481-490. doi: 10.1007/s40119-021-00226-6. Epub 2021 Jun 19.
PMID: 34148211DERIVEDWaddington-Cruz M, Wixner J, Amass L, Kiszko J, Chapman D, Ando Y; THAOS investigators. Characteristics of Patients with Late- vs. Early-Onset Val30Met Transthyretin Amyloidosis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Neurol Ther. 2021 Dec;10(2):753-766. doi: 10.1007/s40120-021-00258-z. Epub 2021 May 22.
PMID: 34024024DERIVEDGonzalez-Duarte A, Barroso F, Mundayat R, Shapiro B. Blood pressure and orthostatic hypotension as measures of autonomic dysfunction in patients from the transthyretin amyloidosis outcomes survey (THAOS). Auton Neurosci. 2019 Dec;222:102590. doi: 10.1016/j.autneu.2019.102590. Epub 2019 Oct 23.
PMID: 31726319DERIVEDHuber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.
PMID: 31353964DERIVEDPinto MV, Pinto LF, Dias M, Rosa RS, Mundayat R, Pedrosa RC, Waddington-Cruz M. Late-onset hereditary ATTR V30M amyloidosis with polyneuropathy: Characterization of Brazilian subjects from the THAOS registry. J Neurol Sci. 2019 Aug 15;403:1-6. doi: 10.1016/j.jns.2019.05.030. Epub 2019 May 28.
PMID: 31163298DERIVEDDamy T, Kristen AV, Suhr OB, Maurer MS, Plante-Bordeneuve V, Yu CR, Ong ML, Coelho T, Rapezzi C; THAOS Investigators. Transthyretin cardiac amyloidosis in continental Western Europe: an insight through the Transthyretin Amyloidosis Outcomes Survey (THAOS). Eur Heart J. 2022 Feb 3;43(5):391-400. doi: 10.1093/eurheartj/ehz173.
PMID: 30938420DERIVEDCruz MW, Pinto MV, Pinto LF, Gervais R, Dias M, Perez C, Mundayat R, Ong ML, Pedrosa RC, Foguel D. Baseline disease characteristics in Brazilian patients enrolled in Transthyretin Amyloidosis Outcome Survey (THAOS). Arq Neuropsiquiatr. 2019 Feb;77(2):96-100. doi: 10.1590/0004-282X20180156.
PMID: 30810593DERIVEDRubin J, Steidley DE, Carlsson M, Ong ML, Maurer MS. Myocardial Contraction Fraction by M-Mode Echocardiography Is Superior to Ejection Fraction in Predicting Mortality in Transthyretin Amyloidosis. J Card Fail. 2018 Aug;24(8):504-511. doi: 10.1016/j.cardfail.2018.07.001. Epub 2018 Aug 17.
PMID: 30010028DERIVEDMundayat R, Stewart M, Alvir J, Short S, Ong ML, Keohane D, Rill D, Sultan MB. Positive Effectiveness of Tafamidis in Delaying Disease Progression in Transthyretin Familial Amyloid Polyneuropathy up to 2 Years: An Analysis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Neurol Ther. 2018 Jun;7(1):87-101. doi: 10.1007/s40120-018-0097-9. Epub 2018 Apr 9.
PMID: 29633228DERIVEDKristen AV, Maurer MS, Rapezzi C, Mundayat R, Suhr OB, Damy T; THAOS investigators. Impact of genotype and phenotype on cardiac biomarkers in patients with transthyretin amyloidosis - Report from the Transthyretin Amyloidosis Outcome Survey (THAOS). PLoS One. 2017 Apr 6;12(4):e0173086. doi: 10.1371/journal.pone.0173086. eCollection 2017.
PMID: 28384285DERIVEDMaurer MS, Hanna M, Grogan M, Dispenzieri A, Witteles R, Drachman B, Judge DP, Lenihan DJ, Gottlieb SS, Shah SJ, Steidley DE, Ventura H, Murali S, Silver MA, Jacoby D, Fedson S, Hummel SL, Kristen AV, Damy T, Plante-Bordeneuve V, Coelho T, Mundayat R, Suhr OB, Waddington Cruz M, Rapezzi C; THAOS Investigators. Genotype and Phenotype of Transthyretin Cardiac Amyloidosis: THAOS (Transthyretin Amyloid Outcome Survey). J Am Coll Cardiol. 2016 Jul 12;68(2):161-72. doi: 10.1016/j.jacc.2016.03.596.
PMID: 27386769DERIVEDDamy T, Maurer MS, Rapezzi C, Plante-Bordeneuve V, Karayal ON, Mundayat R, Suhr OB, Kristen AV. Clinical, ECG and echocardiographic clues to the diagnosis of TTR-related cardiomyopathy. Open Heart. 2016 Feb 8;3(1):e000289. doi: 10.1136/openhrt-2015-000289. eCollection 2016.
PMID: 26870387DERIVEDCoelho T, Maurer MS, Suhr OB. THAOS - The Transthyretin Amyloidosis Outcomes Survey: initial report on clinical manifestations in patients with hereditary and wild-type transthyretin amyloidosis. Curr Med Res Opin. 2013 Jan;29(1):63-76. doi: 10.1185/03007995.2012.754348. Epub 2012 Dec 13.
PMID: 23193944DERIVED
Related Links
Biospecimen
whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
A total of 6718 evaluable participants were enrolled in this study. The database has 6752 participants and the discrepancy in the numbers is due to 1 system screen failure and 33 subjects that are either duplicates or were transferred to a different site.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 5, 2008
Study Start
January 4, 2008
Primary Completion
June 16, 2023
Study Completion
June 19, 2023
Last Updated
November 22, 2024
Results First Posted
November 22, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.