Global Prevalence of ATTR-CM in Participants With HFpEF

Stopped early · Not applicable

Conditions studied: Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection Fraction

In brief

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 \[participants with heart failure with preserved ejection fraction (HFpEF)\].

Key facts

Study ID

NCT04424914

Run by

Pfizer

People needed

347

Starts

2020-12-30

Expected to finish

2023-06-02

Last updated by the study team

2024-07-19

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

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.

Where it is running

• 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
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Stormont Vail Health — Topeka, Kansas, United States
• Cotton O'Neil Heart Center — Topeka, Kansas, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Corewell Health — Grand Rapids, Michigan, United States
• Spectrum Health Medical Group Cardiovascular Medicine — Grand Rapids, Michigan, United States
• Cardiology Associates of North Mississippi, LLC — Tupelo, Mississippi, United States
• Cardiology Associates Research, LLC — Tupelo, Mississippi, United States
• NYU Langone Health — New York, New York, United States
• WakeMed Health and Hospital — Raleigh, North Carolina, United States
• The Jackson Clinic — Jackson, Tennessee, United States
• Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada
• CardioVasc HR Inc — Saint-Jean-sur-Richelieu, Quebec, Canada
• Diex Recherche Trois-Rivieres — Trois-Rivières, Quebec, Canada
• Eastern shore Research Institute LLC — Fairhope, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.