B3461087 Prevalence of ATTR-CM in Participants with HFpEF
Research type
Research Study
Full title
Global Prevalence Of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) In Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
IRAS ID
289902
Contact name
Sandi See Tai
Contact email
Sponsor organisation
Pfizer Inc
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EudraCT Number:, 2020-002378-29; NIHR Number:, CPMS 4714
Duration of Study in the UK
0 years, 6 months, 6 days
Research summary
Research Summary
The purpose of this study is to determine the presence of a disease called transthyretin amyloid cardiomyopathy (ATTR-CM) among patients who have heart failure with preserved ejection fraction (HFpEF) and to look at variations at a country, regional, and global level. Around 40-50% of all patients with heart failure have HFpEF, a condition with typical signs of heart failure but maintained or normal pumping function of the heart (the ejection fraction). In HFpEF the heart failure is often caused instead by heart muscle stiffness and resistance to filling.
Patients with HFpEF may have underlying ATTR-CM. ATTR-CM is a condition which causes accumulation of a protein in the heart causing muscle stiffness and increased risk of heart failure and rhythm disturbances. This study will explore the prevalence of ATTR-CM among patients within a clinically at-risk population, those with HFpEF. This study is a global, multi-centre epidemiology study and will enrol approximately 2000 participants. Participants who are not diagnosed with ATTR-CM will be in this study for approximately 2 months. Participants with suspected ATTR-CM will be in this study for about 9 months. Participants will undergo imaging examinations, blood tests, health questionnaires and physical examinations.Lay summary of study results:
CSR synopsis has been sent to all sites.
Basic Results in lay language will be published on clinicaltrials.gov . An additional lay summary will not be provided.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0156
Date of REC Opinion
31 Aug 2021
REC opinion
Further Information Favourable Opinion