<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04424914</url>
  </required_header>
  <id_info>
    <org_study_id>B3461087</org_study_id>
    <secondary_id>HFpEF ATTR-CM prevalence study</secondary_id>
    <secondary_id>2020-002378-29</secondary_id>
    <secondary_id>ATTR-POP</secondary_id>
    <nct_id>NCT04424914</nct_id>
  </id_info>
  <brief_title>Global Prevalence of ATTR-CM in Participants With HFpEF</brief_title>
  <official_title>GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a global, multi-center study designed to estimate the global prevalence of&#xD;
      transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population&#xD;
      [participants with heart failure with preserved ejection fraction (HFpEF)].&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor terminated study early to not prolong timelines and to enable sharing of data collected&#xD;
    which has potential to better support understanding of the prevalence of ATTR-CM in patients&#xD;
    with HFpEF. Decision was not based on any safety findings.&#xD;
  </why_stopped>
  <start_date type="Actual">December 30, 2020</start_date>
  <completion_date type="Actual">June 2, 2023</completion_date>
  <primary_completion_date type="Actual">June 2, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate of global prevalence of ATTR-CM in HFpEF patients.</measure>
    <time_frame>Visit 1(baseline) through Follow-Up Visit 1 (Day 44)</time_frame>
    <description>Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimate of prevalence of ATTR-CM within region, age and gender</measure>
    <time_frame>Visit 1(baseline) through Follow-Up Visit 1 (Day 44)</time_frame>
    <description>Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of patients diagnosed ATTR-CM on study with WT and hereditary forms among patients diagnosed with ATTR CM</measure>
    <time_frame>Visit 1(baseline) through Follow-Up Visit 1 (Day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association (NYHA) Classification of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM</measure>
    <time_frame>Visit 1(baseline) through Follow-Up Visit 1 (Day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nt-proBNP results of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM</measure>
    <time_frame>Visit 1(baseline) through Follow-Up Visit 1 (Day 44)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Transthyretin Amyloid Cardiomyopathy</condition>
  <condition>Heart Failure With Preserved Ejection Fraction</condition>
  <arm_group>
    <arm_group_label>ATTR-CM positive</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants diagnosed with ATTR-CM by scintigraphy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATTR-CM negative</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants who are scintigraphy negative for ATTR-CM</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Scintigraphy</intervention_name>
    <description>scintigraphy</description>
    <arm_group_label>ATTR-CM negative</arm_group_label>
    <arm_group_label>ATTR-CM positive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medical history of heart failure (HF) with:&#xD;
&#xD;
               1. At least 1 episode with clinical evidence of HF (without hospitalization) by&#xD;
                  signs or symptoms of volume overload or elevated intracardiac pressures that&#xD;
                  required/requires treatment with a diuretic for improvement; OR&#xD;
&#xD;
               2. 1 prior hospitalization for HF.&#xD;
&#xD;
          2. Left ventricular ejection fraction (LVEF) &gt;40%.&#xD;
&#xD;
          3. End-diastolic interventricular septal wall thickness (IVST) ≥12 mm.&#xD;
&#xD;
          4. Willing and able to undergo scintigraphy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%).&#xD;
&#xD;
          2. Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive&#xD;
             coronary disease (&gt;50% stenosis of ≥2 epicardial coronary arteries).&#xD;
&#xD;
          3. Presence or history of any severe valvular heart disease (obstructive or regurgitant).&#xD;
&#xD;
          4. A confirmed diagnosis of a non-amyloid infiltrative cardiomyopathy (ie, cardiac&#xD;
             sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible&#xD;
             causes, hypertrophic obstructive cardiomyopathy with known genetic etiology, or known&#xD;
             pericardial constriction.&#xD;
&#xD;
          5. Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain]&#xD;
             amyloidosis) or prior diagnosis of ATTR-CM.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eastern shore Research Institute LLC</name>
      <address>
        <city>Fairhope</city>
        <state>Alabama</state>
        <zip>36532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Center Research, LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Medical Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinical Research Alliance Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biogenix Molecular</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIRA (Nuclear Imaging Facility)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nucleotron/ Doral Imaging Institute, CIRA DBA</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innova Pharma Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocala Cardiovascular Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Medical Research, LLC</name>
      <address>
        <city>Hazel Crest</city>
        <state>Illinois</state>
        <zip>60429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stormont Vail Health</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton O'Neil Heart Center</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corewell Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health Medical Group Cardiovascular Medicine</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of North Mississippi, LLC</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates Research, LLC</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WakeMed Health and Hospital</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jackson Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center and Children's Hospital</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CardioVasc HR Inc</name>
      <address>
        <city>Saint-Jean-sur-Richelieu</city>
        <state>Quebec</state>
        <zip>J3A 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diex Recherche Trois-Rivieres</name>
      <address>
        <city>Trois-Rivieres</city>
        <state>Quebec</state>
        <zip>G9A 4P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Louis Pradel</name>
      <address>
        <city>Bron Cedex</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Saint-Joseph Saint-Luc</name>
      <address>
        <city>LYON cedex 07</city>
        <zip>69365</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nimes - Hospital Caremeau</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse - Hôpital de Rangueil</name>
      <address>
        <city>Toulouse cedex 9</city>
        <zip>50032 - 31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Médecine Nucléaire de la Doua</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS</name>
      <address>
        <city>Genova</city>
        <state>Genoa</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare</name>
      <address>
        <city>Pisa</city>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya Tokushukai General Hospital</name>
      <address>
        <city>Kasugai</city>
        <state>Aichi</state>
        <zip>487-0016</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka Tokushukai Hospital</name>
      <address>
        <city>Kasuga</city>
        <state>Fukuoka</state>
        <zip>816-0864</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu</name>
      <address>
        <city>Wrocław</city>
        <state>Dolnośląskie</state>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowski Szpital Specjalistyczny im. Jana Pawła II</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-202</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Białymstoku</name>
      <address>
        <city>Białystok</city>
        <state>Podlaskie</state>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital</name>
      <address>
        <city>Łódź</city>
        <state>Łódzkie</state>
        <zip>90-549</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d´Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari De Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital, St George's University Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=B3461087</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prevalence</keyword>
  <keyword>transthyretin amyloid</keyword>
  <keyword>ATTR-CM</keyword>
  <keyword>HFpEF</keyword>
  <keyword>scintigraphy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Amyloidosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04424914
org study id: B3461087
secondary id: HFpEF ATTR-CM prevalence study
secondary id: 2020-002378-29
secondary id: ATTR-POP
nct id: NCT04424914
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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)].
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.
primary purpose: Screening
masking: None (Open Label)
measure: Estimate of global prevalence of ATTR-CM in HFpEF patients.
time frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
description: Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).
measure: Estimate of prevalence of ATTR-CM within region, age and gender
time frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
description: Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).
measure: Prevalence of patients diagnosed ATTR-CM on study with WT and hereditary forms among patients diagnosed with ATTR CM
time frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
measure: New York Heart Association (NYHA) Classification of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM
time frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
measure: Nt-proBNP results of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM
time frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
arm group label: ATTR-CM positive
arm group type: Other
description: Participants diagnosed with ATTR-CM by scintigraphy
arm group label: ATTR-CM negative
arm group type: Other
description: Participants who are scintigraphy negative for ATTR-CM
intervention type: Diagnostic Test
intervention name: Scintigraphy
description: scintigraphy
arm group label: ATTR-CM negative
arm group label: ATTR-CM positive
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Canada
country: France
country: Italy
country: Japan
country: Poland
country: Spain
country: United Kingdom
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=B3461087
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Cardiomyopathies
mesh term: Amyloidosis
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.