- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04424914
Global Prevalence of ATTR-CM in Participants With HFpEF
July 11, 2023 updated by: Pfizer
GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)
This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved ejection fraction (HFpEF)].
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
319
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
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Quebec
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Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1C3
- CardioVasc HR Inc
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Trois-Rivieres, Quebec, Canada, G9A 4P3
- Diex Recherche Trois-Rivieres
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Bron Cedex, France, 69677
- Hopital Louis Pradel
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LYON cedex 07, France, 69365
- Centre Hospitalier Saint-Joseph Saint-Luc
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Nimes, France, 30029
- CHU Nimes - Hospital Caremeau
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Toulouse cedex 9, France, 50032 - 31059
- CHU de Toulouse - Hopital de Rangueil
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Villeurbanne, France, 69100
- Médecine Nucléaire de la Doua
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Genova, Italy, 16132
- U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
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Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
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Pisa, Italy, 56124
- Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare
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BO
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Bologna, BO, Italy, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
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Genoa
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Genova, Genoa, Italy, 16132
- U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Aichi
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Kasugai, Aichi, Japan, 487-0016
- Nagoya Tokushukai General Hospital
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Fukuoka
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Kasuga, Fukuoka, Japan, 816-0864
- Fukuoka Tokushukai Hospital
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-8582
- Keio University Hospital
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Dolnoslaskie
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Wroclaw, Dolnoslaskie, Poland, 50-556
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
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Dolnośląskie
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Wrocław, Dolnośląskie, Poland, 50-556
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
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Malopolskie
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Krakow, Malopolskie, Poland, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawła II
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Podlaskie
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Białystok, Podlaskie, Poland, 15-276
- Uniwersytecki Szpital Kliniczny w Białymstoku
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Łódzkie
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Łódź, Łódzkie, Poland, 90-549
- SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
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Barcelona, Spain, 08035
- Hospital Universitari Vall d´Hebron
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Madrid, Spain, 28034
- Hospital Universitario Ramon y Cajal
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Salamanca, Spain, 37007
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
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Valencia, Spain, 46026
- Hospital Universitari i Politècnic La Fe
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Madrid
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Majadahonda, Madrid, Spain, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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London, United Kingdom, SW17 0QT
- St George's Hospital, St George's University Hospitals NHS Foundation Trust
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Alabama
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Fairhope, Alabama, United States, 36532
- Eastern shore Research Institute LLC
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Huntsville, Alabama, United States, 35801
- Heart Center Research, LLC
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Florida
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Miami, Florida, United States, 33135
- Advance Medical Research Center
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Miami, Florida, United States, 33165
- Biogenix Molecular
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Miami, Florida, United States, 33155
- Bioclinical Research Alliance Inc.
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Miami, Florida, United States, 33165
- CIRA (Nuclear Imaging Facility)
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Miami, Florida, United States, 33165
- Nucleotron/ Doral Imaging Institute, CIRA DBA
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Miami, Florida, United States, 33175
- Innova Pharma Research
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Ocala, Florida, United States, 34471
- Ocala Cardiovascular Research
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Illinois
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Hazel Crest, Illinois, United States, 60429
- Chicago Medical Research, LLC
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Oak Lawn, Illinois, United States, 60453
- Advocate Christ Medical Center
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Kansas
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Topeka, Kansas, United States, 66604
- Stormont Vail Health
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Topeka, Kansas, United States, 66606
- Cotton O'Neil Heart Center
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Corewell Health
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Grand Rapids, Michigan, United States, 49525
- Spectrum Health Medical Group Cardiovascular Medicine
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Mississippi
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Tupelo, Mississippi, United States, 38801
- Cardiology Associates Research, LLC
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Tupelo, Mississippi, United States, 38801
- Cardiology Associates of North Mississippi, LLC
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New York
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New York, New York, United States, 10016
- NYU Langone Health
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North Carolina
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Raleigh, North Carolina, United States, 27610
- WakeMed Health and Hospital
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Tennessee
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Jackson, Tennessee, United States, 38301
- The Jackson Clinic
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Washington
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Spokane, Washington, United States, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Medical history of heart failure (HF) with:
- 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
- 1 prior hospitalization for HF.
- Left ventricular ejection fraction (LVEF) >40%.
- End-diastolic interventricular septal wall thickness (IVST) ≥12 mm.
- Willing and able to undergo scintigraphy.
Exclusion Criteria:
- Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%).
- Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive coronary disease (>50% stenosis of ≥2 epicardial coronary arteries).
- Presence or history of any severe valvular heart disease (obstructive or regurgitant).
- 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.
Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain] amyloidosis) or prior diagnosis of ATTR-CM.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: ATTR-CM positive
Participants diagnosed with ATTR-CM by scintigraphy
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scintigraphy
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Other: ATTR-CM negative
Participants who are scintigraphy negative for ATTR-CM
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scintigraphy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimate of global prevalence of ATTR-CM in HFpEF patients.
Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).
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Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimate of prevalence of ATTR-CM within region, age and gender
Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).
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Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Prevalence of patients diagnosed ATTR-CM on study with WT and hereditary forms among patients diagnosed with ATTR CM
Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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New York Heart Association (NYHA) Classification of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM
Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Nt-proBNP results of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM
Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2020
Primary Completion (Actual)
June 2, 2023
Study Completion (Actual)
June 2, 2023
Study Registration Dates
First Submitted
May 27, 2020
First Submitted That Met QC Criteria
June 5, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
July 13, 2023
Last Update Submitted That Met QC Criteria
July 11, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B3461087
- HFpEF ATTR-CM prevalence study (Other Identifier: Alias Study Number)
- 2020-002378-29 (EudraCT Number)
- ATTR-POP (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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