Study Stopped
Sponsor terminated study early to not prolong timelines and to enable sharing of data collected which has potential to better support understanding of the prevalence of ATTR-CM in patients with HFpEF. Decision was not based on any safety findings.
Global Prevalence of ATTR-CM in Participants With HFpEF
GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)
4 other identifiers
interventional
347
8 countries
51
Brief Summary
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 \[participants with heart failure with preserved ejection fraction (HFpEF)\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Typical duration for not_applicable
51 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
First Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2023
CompletedResults Posted
Study results publicly available
July 19, 2024
CompletedJuly 19, 2024
February 1, 2024
2.4 years
May 27, 2020
February 1, 2024
February 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global Prevalence of ATTR-CM in HFpEF Participants Clinically At-Risk of Disease Among Total Evaluable Participants
Global prevalence of ATTR-CM in HFpEF participants was obtained by dividing the number of participants who were diagnosed with ATTR-CM in the study by the total number of HFpEF participants evaluated. Diagnosis of ATTR-CM was defined as: cardiac scintigraphy Grade 1, with confirmation of ATTR by cardiac biopsy; or cardiac scintigraphy Grade 2 or above. Exact 95% confidence intervals for the prevalence estimates were calculated using the method of Clopper and Pearson.
Day 1
Secondary Outcomes (4)
Global Prevalence of ATTR-CM in Participants With HFpEF Clinically At-Risk of Disease by Subgroups (Regions, Age, Gender) Among Total Evaluable Participants
Day 1
Number of Participants According to TTR Genotypes Among Participants Diagnosed With ATTR-CM
Day 1
Number of HFpEF Participants With and Without ATTR-CM Based on New York Heart Association (NYHA) Classification
Day 1
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in Participants With and Without ATTR-CM
Day 1
Study Arms (2)
ATTR-CM positive
OTHERParticipants diagnosed with ATTR-CM by scintigraphy
ATTR-CM negative
OTHERParticipants who are scintigraphy negative for ATTR-CM
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (51)
Eastern shore Research Institute LLC
Fairhope, Alabama, 36532, United States
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Advance Medical Research Center
Miami, Florida, 33135, United States
Bioclinical Research Alliance Inc.
Miami, Florida, 33155, United States
Biogenix Molecular
Miami, Florida, 33165, United States
CIRA (Nuclear Imaging Facility)
Miami, Florida, 33165, United States
Nucleotron/ Doral Imaging Institute, CIRA DBA
Miami, Florida, 33165, United States
Innova Pharma Research
Miami, Florida, 33175, United States
Ocala Cardiovascular Research
Ocala, Florida, 34471, United States
Chicago Medical Research, LLC
Hazel Crest, Illinois, 60429, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Stormont Vail Health
Topeka, Kansas, 66604, United States
Cotton O'Neil Heart Center
Topeka, Kansas, 66606, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Spectrum Health Medical Group Cardiovascular Medicine
Grand Rapids, Michigan, 49525, United States
Cardiology Associates of North Mississippi, LLC
Tupelo, Mississippi, 38801, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801, United States
NYU Langone Health
New York, New York, 10016, United States
WakeMed Health and Hospital
Raleigh, North Carolina, 27610, United States
The Jackson Clinic
Jackson, Tennessee, 38301, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
CardioVasc HR Inc
Saint-Jean-sur-Richelieu, Quebec, J3A 1C3, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, G9A 4P3, Canada
Hôpital Louis Pradel
Bron, 69677, France
Centre Hospitalier Saint-Joseph Saint-Luc
Lyon, 69365, France
CHU Nimes - Hospital Caremeau
Nîmes, 30029, France
CHU de Toulouse - Hôpital de Rangueil
Toulouse, 50032 - 31059, France
Médecine Nucléaire de la Doua
Villeurbanne, 69100, France
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, 40138, Italy
U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
Genova, Genoa, 16132, Italy
U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
Genova, 16132, Italy
Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
Pavia, 27100, Italy
Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare
Pisa, 56124, Italy
Nagoya Tokushukai General Hospital
Kasugai, Aichi-ken, 487-0016, Japan
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, 816-0864, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Lesser Poland Voivodeship, 31-202, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Podlaskie Voivodeship, 15-276, Poland
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital
Lodz, Łódź Voivodeship, 90-549, Poland
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitari Vall d´Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitari De Bellvitge
Barcelona, 08907, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46026, Spain
St George's Hospital, St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Related Publications (1)
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.
PMID: 39245873DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2020
First Posted
June 11, 2020
Study Start
December 30, 2020
Primary Completion
June 2, 2023
Study Completion
June 2, 2023
Last Updated
July 19, 2024
Results First Posted
July 19, 2024
Record last verified: 2024-02
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.