xml: <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/NCT06030661</url>
    </required_header>
    <id_info>
      <org_study_id>RNN/240/21/KE</org_study_id>
      <nct_id>NCT06030661</nct_id>
    </id_info>
    <brief_title>The HF-POL Study - Multicenter Study of Polish Patients With HF and LVEF &gt;40%</brief_title>
    <acronym>HF-POL</acronym>
    <official_title>The HF-POL Study - Multicenter Study of Polish Patients With Heart Failure and Left Ventricular Ejection Fraction &gt;40%</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Lodz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical University of Silesia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Opole</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Medical University of Warsaw</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Wroclaw Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Military Institute od Medicine National Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jagiellonian University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Medical University of Bialystok</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Świętokrzyskie Cardiology Center of Kielce</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Regional Specialist Hospital in Rybnik</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of Lodz</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        HF-POL is the first Polish multicenter observational prospective registry of patients with&#xD;
        heart failure and ejection fraction more than 40% designed by Heart Failure Association of&#xD;
        the Polish Cardiac Society. The purpose of this study was to provide first characteristics of&#xD;
        Polish population patients with heart failure and EF&gt;40% and to provide a better&#xD;
        understanding of medical practice, based on observational data, including diagnosis,&#xD;
        treatment, and prognosis over 3-year follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        HF-POL is the first Polish multicenter observational prospective registry of patients with&#xD;
        heart failure and ejection fraction more than 40%. HF-POL study is conducted by the Heart&#xD;
        Failure Association of the Polish Cardiac Society in cooperation with the Committee for&#xD;
        Clinical Initiatives of the Executive Board as part of the Scientific Platform initiative.&#xD;
        The leading center of the study is the Military Medical Academy Memorial Teaching Hospital of&#xD;
        the Medical University of Lodz, Poland. The Primary Investigator is Malgorzata Lelonek; the&#xD;
        Steering Committee includes Malgorzata Lelonek, Mariusz Gasior, and Marcin Grabowski. The&#xD;
        study was approved by the Bioethics Committee at the Medical University of Lodz (No.&#xD;
        RNN/240/21/KE; October 21, 2021).&#xD;
  &#xD;
        The purpose of this study was to provide first characteristics of Polish population patients&#xD;
        with heart failure and EF&gt;40% and to provide a better understanding of medical practice,&#xD;
        based on observational data, including diagnosis, treatment, and prognosis over 3-year&#xD;
        follow-up. Patients have been recruited at each participating center since that center's&#xD;
        activation on the eCRF.biz platform (a clinical data management system,&#xD;
        https://rejestr.gbbsoft.pl/hf-pol). We collected data included demographics, medical history,&#xD;
        concomitant medications, selected laboratory, electrocardiographic and echocardiographic&#xD;
        results as well ascomorbidities. Patients are diagnosed and treated according to the current&#xD;
        clinical practice guidelines and the standard of care at participating centers.&#xD;
  &#xD;
        All consecutive patients meeting the inclusion and exclusion criteria are being enrolled.&#xD;
  &#xD;
        Heart Failure should be recognized according to the 2021 ESC guidelines. The study allows&#xD;
        recruitment based on results from medical records, especially for outpatients with a history&#xD;
        of Heart Failure. The study population includes patients with Heart Failure and LVEF &gt;40%. In&#xD;
        total, a minimum of 1000 patients from 14 Polish centers will be enrolled.&#xD;
  &#xD;
        Patients will stay in 3-year follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 7, 2022</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Death andr/or the first heart failure hospitalisation</measure>
      <time_frame>From randomisation to end-of-study ( 3 years)</time_frame>
      <description>Occurrence of all-cause mortality and/or the first heart failure hospitalisation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>All heart failure hospitalisations</measure>
      <time_frame>From randomisation to end-of-study (3 years)</time_frame>
      <description>Number of heart failure hospitalisations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All cause hospitalisations</measure>
      <time_frame>From randomisation to end-of-study ( 3 years)</time_frame>
      <description>Number of all cause hospitalisation</description>
    </secondary_outcome>
    <enrollment type="Actual">1497</enrollment>
    <condition>Heart Failure</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Polish population with Heart Failure and EF &gt;40%.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age &gt;18 years&#xD;
  &#xD;
            -  documented EF &gt;40%&#xD;
  &#xD;
            -  symptomatic chronic Heart Failure or acute Heart Failure (worsening of chronic Heart&#xD;
               Failure or Heart Failure de novo) requiring hospitalization and intravenous agents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age &lt;18 years&#xD;
  &#xD;
            -  dyspnea due to other causes than Heart Failure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Malgorzata Lelonek, Prof.MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical University of Lodz</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Department of Noninvasive Cardiology, Medical University of Lodz</name>
        <address>
          <city>Łódź</city>
          <zip>90-549</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>heart failure with preserved ejection fraction</keyword>
    <keyword>heart failure with mildly reduced ejection fraction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030661
  org study id: RNN/240/21/KE
  nct id: NCT06030661
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  HF-POL is the first Polish multicenter observational prospective registry of patients with
        heart failure and ejection fraction more than 40% designed by Heart Failure Association of
        the Polish Cardiac Society. The purpose of this study was to provide first characteristics of
        Polish population patients with heart failure and EF>40% and to provide a better
        understanding of medical practice, based on observational data, including diagnosis,
        treatment, and prognosis over 3-year follow-up.
  HF-POL is the first Polish multicenter observational prospective registry of patients with
        heart failure and ejection fraction more than 40%. HF-POL study is conducted by the Heart
        Failure Association of the Polish Cardiac Society in cooperation with the Committee for
        Clinical Initiatives of the Executive Board as part of the Scientific Platform initiative.
        The leading center of the study is the Military Medical Academy Memorial Teaching Hospital of
        the Medical University of Lodz, Poland. The Primary Investigator is Malgorzata Lelonek; the
        Steering Committee includes Malgorzata Lelonek, Mariusz Gasior, and Marcin Grabowski. The
        study was approved by the Bioethics Committee at the Medical University of Lodz (No.
        RNN/240/21/KE; October 21, 2021).
  
        The purpose of this study was to provide first characteristics of Polish population patients
        with heart failure and EF>40% and to provide a better understanding of medical practice,
        based on observational data, including diagnosis, treatment, and prognosis over 3-year
        follow-up. Patients have been recruited at each participating center since that center's
        activation on the eCRF.biz platform (a clinical data management system,
        https://rejestr.gbbsoft.pl/hf-pol). We collected data included demographics, medical history,
        concomitant medications, selected laboratory, electrocardiographic and echocardiographic
        results as well ascomorbidities. Patients are diagnosed and treated according to the current
        clinical practice guidelines and the standard of care at participating centers.
  
        All consecutive patients meeting the inclusion and exclusion criteria are being enrolled.
  
        Heart Failure should be recognized according to the 2021 ESC guidelines. The study allows
        recruitment based on results from medical records, especially for outpatients with a history
        of Heart Failure. The study population includes patients with Heart Failure and LVEF >40%. In
        total, a minimum of 1000 patients from 14 Polish centers will be enrolled.
  
        Patients will stay in 3-year follow-up.
  observational model: Cohort
  time perspective: Prospective
  measure: Death andr/or the first heart failure hospitalisation
  time frame: From randomisation to end-of-study ( 3 years)
  description: Occurrence of all-cause mortality and/or the first heart failure hospitalisation
  measure: All heart failure hospitalisations
  time frame: From randomisation to end-of-study (3 years)
  description: Number of heart failure hospitalisations
  measure: All cause hospitalisations
  time frame: From randomisation to end-of-study ( 3 years)
  description: Number of all cause hospitalisation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Malgorzata Lelonek, Prof.MD, PhD
  role: Principal Investigator
  affiliation: Medical University of Lodz
  facility: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Heart Failure