Global Prevalence of ATTR-CM in Participants With HFpEF

Last updated: February 1, 2024
Sponsor: Pfizer
Overall Status: Terminated

Phase

N/A

Condition

Heart Failure

Amyloidosis

Congestive Heart Failure

Treatment

Scintigraphy

Clinical Study ID

NCT04424914
B3461087
2020-002378-29
HFpEF ATTR-CM prevalence study
ATTR-POP
  • Ages > 60
  • All Genders

Study 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)].

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Medical history of heart failure (HF) with:

  2. At least 1 episode with clinical evidence of HF (without hospitalization) bysigns or symptoms of volume overload or elevated intracardiac pressures thatrequired/requires treatment with a diuretic for improvement; OR

  3. 1 prior hospitalization for HF.

  4. Left ventricular ejection fraction (LVEF) >40%.

  5. End-diastolic interventricular septal wall thickness (IVST) ≥12 mm.

  6. Willing and able to undergo scintigraphy.

Exclusion

Exclusion Criteria:

  1. Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%).

  2. Prior clinical history of myocardial infarction, CABG or multi-vessel obstructivecoronary disease (>50% stenosis of ≥2 epicardial coronary arteries).

  3. Presence or history of any severe valvular heart disease (obstructive orregurgitant).

  4. A confirmed diagnosis of a non-amyloid infiltrative cardiomyopathy (ie, cardiacsarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversiblecauses, hypertrophic obstructive cardiomyopathy with known genetic etiology, orknown pericardial constriction.

  5. Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain]amyloidosis) or prior diagnosis of ATTR-CM.

Study Design

Total Participants: 347
Treatment Group(s): 1
Primary Treatment: Scintigraphy
Phase:
Study Start date:
December 30, 2020
Estimated Completion Date:
June 02, 2023

Connect with a study center

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • CardioVasc HR Inc

    Saint-Jean-sur-Richelieu, Quebec J3A 1C3
    Canada

    Site Not Available

  • Diex Recherche Trois-Rivieres

    Trois-Rivieres, Quebec G9A 4P3
    Canada

    Site Not Available

  • Hôpital Louis Pradel

    Bron Cedex, 69677
    France

    Site Not Available

  • Centre Hospitalier Saint-Joseph Saint-Luc

    LYON cedex 07, 69365
    France

    Site Not Available

  • CHU Nimes - Hospital Caremeau

    Nimes, 30029
    France

    Site Not Available

  • CHU de Toulouse - Hôpital de Rangueil

    Toulouse cedex 9, 50032 - 31059
    France

    Site Not Available

  • Médecine Nucléaire de la Doua

    Villeurbanne, 69100
    France

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, BO 40138
    Italy

    Site Not Available

  • U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS

    Genova, 16132
    Italy

    Site Not Available

  • A.O.U. Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche

    Pavia, 27100
    Italy

    Site Not Available

  • Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare

    Pisa, 56124
    Italy

    Site Not Available

  • Nagoya Tokushukai General Hospital

    Kasugai, Aichi 487-0016
    Japan

    Site Not Available

  • Fukuoka Tokushukai Hospital

    Kasuga, Fukuoka 816-0864
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-ku, Tokyo 160-8582
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wrocław, Dolnośląskie 50-556
    Poland

    Site Not Available

  • Krakowski Szpital Specjalistyczny im. Jana Pawła II

    Krakow, Malopolskie 31-202
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Białystok, Podlaskie 15-276
    Poland

    Site Not Available

  • SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital

    Łódź, Łódzkie 90-549
    Poland

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari De Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Universitari Vall d´Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • St George's Hospital, St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Eastern shore Research Institute LLC

    Fairhope, Alabama 36532
    United States

    Site Not Available

  • Heart Center Research, LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Advance Medical Research Center

    Miami, Florida 33135
    United States

    Site Not Available

  • Bioclinical Research Alliance Inc.

    Miami, Florida 33155
    United States

    Site Not Available

  • Biogenix Molecular

    Miami, Florida 33165
    United States

    Site Not Available

  • CIRA (Nuclear Imaging Facility)

    Miami, Florida 33165
    United States

    Site Not Available

  • Innova Pharma Research

    Miami, Florida 33175
    United States

    Site Not Available

  • Nucleotron/ Doral Imaging Institute, CIRA DBA

    Miami, Florida 33165
    United States

    Site Not Available

  • Ocala Cardiovascular Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • Chicago Medical Research, LLC

    Hazel Crest, Illinois 60429
    United States

    Site Not Available

  • Advocate Christ Medical Center

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Cotton O'Neil Heart Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Stormont Vail Health

    Topeka, Kansas 66604
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Spectrum Health Medical Group Cardiovascular Medicine

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Cardiology Associates of North Mississippi, LLC

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • WakeMed Health and Hospital

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • The Jackson Clinic

    Jackson, Tennessee 38301
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington 99204
    United States

    Site Not Available

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