Global Prevalence of ATTR-CM in Participants With HFpEF
NCT ID: NCT04424914
Last Updated: 2024-07-19
Study Results
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View full resultsBasic Information
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TERMINATED
NA
347 participants
INTERVENTIONAL
2020-12-30
2023-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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ATTR-CM positive
Participants diagnosed with ATTR-CM by scintigraphy
Scintigraphy
scintigraphy
ATTR-CM negative
Participants who are scintigraphy negative for ATTR-CM
Scintigraphy
scintigraphy
Interventions
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Scintigraphy
scintigraphy
Eligibility Criteria
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Inclusion Criteria
1. At least 1 episode with clinical evidence of HF (without hospitalization) by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement; OR
2. 1 prior hospitalization for HF.
2. Left ventricular ejection fraction (LVEF) \>40%.
3. End-diastolic interventricular septal wall thickness (IVST) ≥12 mm.
4. Willing and able to undergo scintigraphy.
Exclusion Criteria
2. Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive coronary disease (\>50% stenosis of ≥2 epicardial coronary arteries).
3. Presence or history of any severe valvular heart disease (obstructive or regurgitant).
4. A confirmed diagnosis of a non-amyloid infiltrative cardiomyopathy (ie, cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy with known genetic etiology, or known pericardial constriction.
5. Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary \[light chain\] amyloidosis) or prior diagnosis of ATTR-CM.
\-
60 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Eastern shore Research Institute LLC
Fairhope, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Advance Medical Research Center
Miami, Florida, United States
Bioclinical Research Alliance Inc.
Miami, Florida, United States
Biogenix Molecular
Miami, Florida, United States
CIRA (Nuclear Imaging Facility)
Miami, Florida, United States
Nucleotron/ Doral Imaging Institute, CIRA DBA
Miami, Florida, United States
Innova Pharma Research
Miami, Florida, United States
Ocala Cardiovascular Research
Ocala, Florida, United States
Chicago Medical Research, LLC
Hazel Crest, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Stormont Vail Health
Topeka, Kansas, United States
Cotton O'Neil Heart Center
Topeka, Kansas, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Corewell Health
Grand Rapids, Michigan, United States
Spectrum Health Medical Group Cardiovascular Medicine
Grand Rapids, Michigan, United States
Cardiology Associates of North Mississippi, LLC
Tupelo, Mississippi, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
NYU Langone Health
New York, New York, United States
WakeMed Health and Hospital
Raleigh, North Carolina, United States
The Jackson Clinic
Jackson, Tennessee, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
CardioVasc HR Inc
Saint-Jean-sur-Richelieu, Quebec, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
Hôpital Louis Pradel
Bron, , France
Centre Hospitalier Saint-Joseph Saint-Luc
Lyon, , France
CHU Nimes - Hospital Caremeau
Nîmes, , France
CHU de Toulouse - Hôpital de Rangueil
Toulouse, , France
Médecine Nucléaire de la Doua
Villeurbanne, , France
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, Italy
U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
Genova, Genoa, Italy
U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
Genova, , Italy
Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
Pavia, , Italy
Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare
Pisa, , Italy
Nagoya Tokushukai General Hospital
Kasugai, Aichi-ken, Japan
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Okayama University Hospital
Okayama, , Japan
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Podlaskie Voivodeship, Poland
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital
Lodz, Łódź Voivodeship, Poland
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitari Vall d´Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari De Bellvitge
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
St George's Hospital, St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Yun S, Palladini G, Anderson LJ, Cariou E, Wang R, Angeli FS, Ebede B, Garcia-Pavia P. International prevalence of transthyretin amyloid cardiomyopathy in high-risk patients with heart failure and preserved or mildly reduced ejection fraction. Amyloid. 2024 Dec;31(4):291-301. doi: 10.1080/13506129.2024.2398446. Epub 2024 Sep 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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HFpEF ATTR-CM prevalence study
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002378-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ATTR-POP
Identifier Type: OTHER
Identifier Source: secondary_id
B3461087
Identifier Type: -
Identifier Source: org_study_id
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