ABOUT THIS STUDY
FOR MORE INFORMATION
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1. Medical history of heart failure (HF) with:
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.
1. Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%).
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.
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Descriptive Information | |||||
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Brief Title ICMJE | Global Prevalence of ATTR-CM in Participants With HFpEF | ||||
Official Title ICMJE | GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF) | ||||
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)]. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: To determine global prevalence of transthyretin amyloid cardiomyopathy in participants diagnosed with heart failure with preserved ejection fraction. No study treatment will be dispensed however, participants will undergo scintigraphy. Masking: None (Open Label)Primary Purpose: Screening | ||||
Condition ICMJE |
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Intervention ICMJE | Diagnostic Test: Scintigraphy
scintigraphy | ||||
Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 2000 | ||||
Original Estimated Enrollment ICMJE | 2500 | ||||
Estimated Study Completion Date ICMJE | June 9, 2022 | ||||
Estimated Primary Completion Date | January 24, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Spain, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04424914 | ||||
Other Study ID Numbers ICMJE | B3461087 ATRIS ( Other Identifier: Alias Study Number ) HFpEF ATTR-CM prevalence study ( Other Identifier: Alias Study Number ) 2020-002378-29 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |