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/NCT05963282</url>
    </required_header>
    <id_info>
      <org_study_id>CLCZ696B2037</org_study_id>
      <nct_id>NCT05963282</nct_id>
    </id_info>
    <brief_title>Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients</brief_title>
    <official_title>Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <brief_summary>
      <textblock>
        This was a non-interventional retrospective cohort study of de novo heart failure with&#xD;
        reduced ejection fraction (HFrEF) patients (aged ≥18 years) commencing first-line treatment&#xD;
        on either sacubitril/valsartan or commencing or continuing angiotensin-converting enzyme&#xD;
        inhibitors (ACEi)/angiotensin receptor blocker (ARB) therapy for HF in the United States (US)&#xD;
        using the secondary source of data, Optum Electronic Health Records (EHR).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 29, 2021</start_date>
    <completion_date type="Actual">July 19, 2022</completion_date>
    <primary_completion_date type="Actual">July 19, 2022</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>Total number of all-cause hospitalizations</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to first all-cause hospitalization</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and proportion of HF-specific inpatient hospitalizations</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and proportion of HF-related inpatient hospitalizations</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and proportion of cardiovascular (CV)-specific inpatient hospitalizations</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) all-cause inpatient hospitalizations</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) HF-specific inpatient hospitalizations.</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and proportion of patients with ≥1 implantable cardioverter defibrillator (ICD) insertion during a hospitalization or during an emergency room (ER) visit for both the sacubitril/valsartan and ACEi/ARB cohorts</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and proportion of non-HF inpatient hospitalizations</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and proportion of non-CV inpatient hospitalizations</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dosages and dose changes of sacubitril/valsartan administered</measure>
      <time_frame>Up to approximately 5 years</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">9870</enrollment>
    <condition>de Novo Heart Failure</condition>
    <arm_group>
      <arm_group_label>Sacubitril/valsartan</arm_group_label>
      <description>Prescribed sacubitril/valsartan</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ACEi/ARB</arm_group_label>
      <description>Prescribed ACEi or ARB</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This was a retrospective, noninterventional cohort study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Sacubitril/valsartan cohort:&#xD;
  &#xD;
            -  Prescribed sacubitril/valsartan within the identification period.&#xD;
  &#xD;
            -  With at least one International Classification of Diseases, 9th Revision (ICD)-9 or&#xD;
               10th Revision (ICD-10) code for diagnosis of HF within 30 days prior to the index date&#xD;
               (including index date), that had non-missing sex and year of birth data.&#xD;
  &#xD;
            -  Active in the database for 759 days prior to index.&#xD;
  &#xD;
            -  With left ventricular ejection fraction (LVEF) ≤ 40% known prior to index day&#xD;
               (including index date).&#xD;
  &#xD;
            -  That were treated as part of the integrated delivery network (IDN).&#xD;
  &#xD;
          ACEi/ARB cohort:&#xD;
  &#xD;
            -  Prescribed ACEi or ARB within the identification period.&#xD;
  &#xD;
            -  With at least one ICD-9 or ICD-10 code for diagnosis of HF within 30 days prior to the&#xD;
               index date (including index date), that have non-missing sex and year of birth data.&#xD;
  &#xD;
            -  Active in the database for 759 days prior to index.&#xD;
  &#xD;
            -  With LVEF ≤ 40% known prior to index day (including index date).&#xD;
  &#xD;
            -  That were treated as part of the IDN.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
          Sacubitril/valsartan cohort:&#xD;
  &#xD;
            -  That were &lt; 18 years old at index date.&#xD;
  &#xD;
            -  That were prescribed sacubitril/valsartan within the baseline period or identification&#xD;
               period (whichever was earlier) at any time prior to the index date (excluding).&#xD;
  &#xD;
            -  With one or more ICD-9 or ICD-10 codes for diagnosis of HF within the baseline period,&#xD;
               excluding the 30 days prior to index in which HF was initially identified (patient&#xD;
               should have had no prior history of HF).&#xD;
  &#xD;
            -  That were prescribed ACEi/ARB &gt; 2 days before index date, and within 30 days after a&#xD;
               HF diagnosis during the identification period (i.e. any patient included in the&#xD;
               ACEi/ARB cohort with an earlier index date, regardless of whether LVEF was ≤ 40% or &gt;&#xD;
               40%)&#xD;
  &#xD;
            -  With LVEF ≤ 10% as the closest value to index date (including).&#xD;
  &#xD;
          ACEi/ARB cohort:&#xD;
  &#xD;
            -  That were &lt; 18 years old at index date.&#xD;
  &#xD;
            -  That were prescribed sacubitril/valsartan within the baseline period or identification&#xD;
               period (whichever was earlier) at any time prior to the index date, on the index date,&#xD;
               or until ≤ 2 days after the index date.&#xD;
  &#xD;
            -  With one or more ICD-9 or ICD-10 codes for diagnosis of HF within the baseline period,&#xD;
               excluding the 30 days prior to index in which HF was initially identified (patient&#xD;
               should have had no prior history of HF).&#xD;
  &#xD;
            -  With LVEF ≤ 10% as the closest value to index date (including).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Novartis</name>
        <address>
          <city>East Hanover</city>
          <state>New Jersey</state>
          <zip>07936</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05963282
  org study id: CLCZ696B2037
  nct id: NCT05963282
  lead sponsor: 
  This was a non-interventional retrospective cohort study of de novo heart failure with
        reduced ejection fraction (HFrEF) patients (aged ≥18 years) commencing first-line treatment
        on either sacubitril/valsartan or commencing or continuing angiotensin-converting enzyme
        inhibitors (ACEi)/angiotensin receptor blocker (ARB) therapy for HF in the United States (US)
        using the secondary source of data, Optum Electronic Health Records (EHR).
  observational model: Cohort
  time perspective: Retrospective
  measure: Total number of all-cause hospitalizations
  time frame: Up to approximately 5 years
  measure: Time to first all-cause hospitalization
  time frame: Up to approximately 5 years
  measure: Number and proportion of HF-specific inpatient hospitalizations
  time frame: Up to approximately 5 years
  measure: Number and proportion of HF-related inpatient hospitalizations
  time frame: Up to approximately 5 years
  measure: Number and proportion of cardiovascular (CV)-specific inpatient hospitalizations
  time frame: Up to approximately 5 years
  measure: Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) all-cause inpatient hospitalizations
  time frame: Up to approximately 5 years
  measure: Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) HF-specific inpatient hospitalizations.
  time frame: Up to approximately 5 years
  measure: Number and proportion of patients with ≥1 implantable cardioverter defibrillator (ICD) insertion during a hospitalization or during an emergency room (ER) visit for both the sacubitril/valsartan and ACEi/ARB cohorts
  time frame: Up to approximately 5 years
  measure: Number and proportion of non-HF inpatient hospitalizations
  time frame: Up to approximately 5 years
  measure: Number and proportion of non-CV inpatient hospitalizations
  time frame: Up to approximately 5 years
  measure: Dosages and dose changes of sacubitril/valsartan administered
  time frame: Up to approximately 5 years
  arm group label: Sacubitril/valsartan
  description: Prescribed sacubitril/valsartan
  arm group label: ACEi/ARB
  description: Prescribed ACEi or ARB
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Heart Failure