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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
347
scintigraphy
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.
Time frame: Day 1
Global Prevalence of ATTR-CM in Participants With HFpEF Clinically At-Risk of Disease by Subgroups (Regions, Age, Gender) Among Total Evaluable Participants
The prevalence of ATTR-CM in HFpEF participants was evaluated for subgroups including regions (North America, Europe, and Asia), age categories (60-64 years, 65-69 years, 70-74 years, 75-79 years, 80-85 years, 85-89 years, \>=90 years), and gender (male, female). The estimate of prevalence was defined as the number of participants meeting the diagnosis criteria of ATTR-CM divided by the number of evaluable participants in the study in the given subgroup category. 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.
Time frame: Day 1
Number of Participants According to TTR Genotypes Among Participants Diagnosed With ATTR-CM
Number of participants diagnosed with ATTR-CM were evaluated for TTR genotypes (wild-type or hereditary form).
Time frame: Day 1
Number of HFpEF Participants With and Without ATTR-CM Based on New York Heart Association (NYHA) Classification
Participants were evaluated using the NYHA classification at Day 1. Class I: participants with cardiac disease but without resulting limitations of physical activity. Class II: participants with cardiac disease resulting in slight limitation of physical activity. Class III: participants with cardiac disease resulting in marked limitation of physical activity. Class IV: participants with cardiac disease resulting in inability to carry on any physical activity without discomfort.
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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
...and 41 more locations
Time frame: Day 1
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in Participants With and Without ATTR-CM
Participants were evaluated using NT-proBNP cardiac biomarker that was assessed at Day 1.
Time frame: Day 1