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/NCT05974189</url>
    </required_header>
    <id_info>
      <org_study_id>22562</org_study_id>
      <nct_id>NCT05974189</nct_id>
    </id_info>
    <brief_title>The VERIFY Study: An Observational Study Called VERIFY to Learn More About the Use of Vericiguat in People With Chronic Heart Failure With Reduced Ejection Fraction</brief_title>
    <official_title>Assessing Vericiguat for the Management of Heart Failure With Reduced Ejection Fraction Using HealthVerity Data</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bayer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bayer</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 is an observational study in which the health data of people with chronic heart failure&#xD;
        with reduced ejection fraction (HFrEF) are collected using administrative claims data.&#xD;
  &#xD;
        In observational studies, only observations are made and participants do not receive any&#xD;
        advice or changes to healthcare.&#xD;
  &#xD;
        Chronic HFrEF is a longterm condition that occurs when the heart is weak and cannot pump&#xD;
        enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of&#xD;
        oxygen which the body requires to function properly. The common symptoms include&#xD;
        breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated,&#xD;
        heart failure can lead to other serious health problems, including damage to other organs,&#xD;
        which may result in hospital stays and even death.&#xD;
  &#xD;
        Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase&#xD;
        (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result,&#xD;
        the heart is able to pump better.&#xD;
  &#xD;
        Vericiguat was approved for the treatment of HFrEF based on the results of a study called&#xD;
        VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or&#xD;
        hospitalization due to heart failure. There is limited information available about the use of&#xD;
        vericiguat for the treatment of HFrEF under realworld conditions.&#xD;
  &#xD;
        The main purpose of this study is to collect information about the characteristics of people&#xD;
        with HFrEF, who are on vericiguat in addition to at least one standard treatment. Researchers&#xD;
        will collect information about participants' basic characteristics, including their age,&#xD;
        gender, other health conditions they may have, and the medicines they may be taking.&#xD;
  &#xD;
        The data will come from administrative claims data for people in the United States of America&#xD;
        who were diagnosed with HFrEF between January 2020 and June 2022.&#xD;
  &#xD;
        In this study, only available data from routine care is collected. No visits or tests are&#xD;
        required as part of this study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Descriptive summary of baseline characteristics of patients administered vericiguat in addition to at least one GDMT in patients with HFrEF</measure>
      <time_frame>Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time tovisit or first hospitalization for HF or cardiovascular (CV) death first emergency room (ER)</measure>
      <time_frame>Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to CV mortality</measure>
      <time_frame>Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first ER visit or hospitalization for HF</measure>
      <time_frame>Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to all-cause death</measure>
      <time_frame>Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Chronic Heart Failure With Reduced Ejection Fraction</condition>
    <arm_group>
      <arm_group_label>HFrEF patients treated with at least one GDMT and with vericiguat</arm_group_label>
      <description>This study will use anonymized real-world data from HealthVerity open and closed Medical and Pharmacy Claims.&#xD;
  Adult patients with a diagnosis of HFrEF and received vericiguat added to at least one guideline directed medical therapy (GDMT), from January 1, 2021 through June 30, 2022 will be included in this retrospective cohort analysis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HFrEF patients treated with at least one GDMT, without vericiguat</arm_group_label>
      <description>This study will use anonymized real-world data from HealthVerity open and closed Medical and Pharmacy Claims.&#xD;
  Adult patients with a diagnosis of HFrEF and received at least one GDMT (without vericiguat), from January 1, 2021 through June 30, 2022 will be included in this retrospective cohort analysis.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This retrospective cohort analysis in data from the deidentified, United States&#xD;
          HealthVerity Claims, Pharmacy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18-years old&#xD;
  &#xD;
            -  Have proven or presumed HFrEF&#xD;
  &#xD;
            -  Have received ≥1 GDMTs for HFrEF&#xD;
  &#xD;
            -  All patients will be required to have continuous enrollment in the HealthVerity data&#xD;
               set during the pre-index date (baseline period) of at least 90-days.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Bayer</name>
        <address>
          <city>Berlin</city>
          <zip>13342</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <link>
      <url>https://clinicaltrials.bayer.com/</url>
      <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HFrEF</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.</ipd_description>
    </patient_data>
    <!-- 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/NCT05974189
  org study id: 22562
  nct id: NCT05974189
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational study in which the health data of people with chronic heart failure
        with reduced ejection fraction (HFrEF) are collected using administrative claims data.
  
        In observational studies, only observations are made and participants do not receive any
        advice or changes to healthcare.
  
        Chronic HFrEF is a longterm condition that occurs when the heart is weak and cannot pump
        enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of
        oxygen which the body requires to function properly. The common symptoms include
        breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated,
        heart failure can lead to other serious health problems, including damage to other organs,
        which may result in hospital stays and even death.
  
        Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase
        (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result,
        the heart is able to pump better.
  
        Vericiguat was approved for the treatment of HFrEF based on the results of a study called
        VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or
        hospitalization due to heart failure. There is limited information available about the use of
        vericiguat for the treatment of HFrEF under realworld conditions.
  
        The main purpose of this study is to collect information about the characteristics of people
        with HFrEF, who are on vericiguat in addition to at least one standard treatment. Researchers
        will collect information about participants' basic characteristics, including their age,
        gender, other health conditions they may have, and the medicines they may be taking.
  
        The data will come from administrative claims data for people in the United States of America
        who were diagnosed with HFrEF between January 2020 and June 2022.
  
        In this study, only available data from routine care is collected. No visits or tests are
        required as part of this study.
  observational model: Cohort
  time perspective: Retrospective
  measure: Descriptive summary of baseline characteristics of patients administered vericiguat in addition to at least one GDMT in patients with HFrEF
  time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
  measure: Time tovisit or first hospitalization for HF or cardiovascular (CV) death first emergency room (ER)
  time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
  measure: Time to CV mortality
  time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
  measure: Time to first ER visit or hospitalization for HF
  time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
  measure: Time to all-cause death
  time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
  arm group label: HFrEF patients treated with at least one GDMT and with vericiguat
  description: This study will use anonymized real-world data from HealthVerity open and closed Medical and Pharmacy Claims.
  Adult patients with a diagnosis of HFrEF and received vericiguat added to at least one guideline directed medical therapy (GDMT), from January 1, 2021 through June 30, 2022 will be included in this retrospective cohort analysis.
  arm group label: HFrEF patients treated with at least one GDMT, without vericiguat
  description: This study will use anonymized real-world data from HealthVerity open and closed Medical and Pharmacy Claims.
  Adult patients with a diagnosis of HFrEF and received at least one GDMT (without vericiguat), from January 1, 2021 through June 30, 2022 will be included in this retrospective cohort analysis.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Germany
  url: https://clinicaltrials.bayer.com/
  description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: No
  ipd description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.