Transthyretin Amyloid Cardiomyopathy Clinical Trial

Global Prevalence of ATTR-CM in Participants With HFpEF

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)].

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Estimated Enrollment:

319

Study ID:

NCT04424914

Recruitment Status:

Terminated

Sponsor:

Pfizer

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There are 47 Locations for this study

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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 4, Canada
CardioVasc HR Inc
Saint-Jean-sur-Richelieu Quebec, J3A 1, Canada
Diex Recherche Trois-Rivieres
Trois-Rivieres Quebec, G9A 4, Canada
Hôpital Louis Pradel
Bron Cedex , 69677, France
Centre Hospitalier Saint-Joseph Saint-Luc
LYON cedex 07 , 69365, France
CHU Nimes - Hospital Caremeau
Nimes , 30029, France
CHU de Toulouse - Hôpital de Rangueil
Toulouse cedex 9 , 50032, 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, 487-0, Japan
Fukuoka Tokushukai Hospital
Kasuga Fukuoka, 816-0, Japan
Keio University Hospital
Shinjuku-ku Tokyo, 160-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw Dolnoslaskie, 50-55, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wrocław Dolnośląskie, 50-55, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow Malopolskie, 31-20, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Białystok Podlaskie, 15-27, Poland
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital
Łódź Łódzkie, 90-54, 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 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Estimated Enrollment:

319

Study ID:

NCT04424914

Recruitment Status:

Terminated

Sponsor:


Pfizer

How clear is this clinincal trial information?

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