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/NCT06024746</url>
    </required_header>
    <id_info>
      <org_study_id>202303CPC</org_study_id>
      <nct_id>NCT06024746</nct_id>
    </id_info>
    <brief_title>A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)</brief_title>
    <acronym>CONFIRMATION</acronym>
    <official_title>Combined Efficacy and Safety of an Early, Intensive, Management Strategy With Finerenone and SGLT2 Inhibitor in Patients Hospitalized With Heart Failure (CONFIRMATION-HF)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Colorado Prevention Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Saint Luke's Hospital of Kansas City</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bayer</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Colorado Prevention Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Combination therapy with finerenone with empagliflozin will be compared to usual care to&#xD;
        determine the efficacy and safety of treatment in patients hospitalized with heart failure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an international, randomized, controlled, open-label, trial of an early, intensive&#xD;
        management strategy using the combination of finerenone plus sodium-glucose co-transporter 2&#xD;
        inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 2024</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical benefit</measure>
      <time_frame>6 months</time_frame>
      <description>Hierarchical composite of the following assessed by the win-ratio:&#xD;
  Time to death from any cause&#xD;
  Number of HF events&#xD;
  Time to first HF event&#xD;
  Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of serious adverse events (AEs).</measure>
      <time_frame>6 months</time_frame>
      <description>- Serious AEs (excluding efficacy endpoints).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of adverse events leading to discontinuation of study drug.</measure>
      <time_frame>6 months</time_frame>
      <description>- AEs leading to discontinuation of finerenone or empagliflozin.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of deaths from any cause and total HF events.</measure>
      <time_frame>6 months</time_frame>
      <description>- All-cause mortality and total HF events (first and recurrent).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of HF events at Day 90.</measure>
      <time_frame>90 days</time_frame>
      <description>- Total (first and recurrent) HF events.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Finerenone plus empagliflozin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual care management</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Finerenone</intervention_name>
      <description>Oral finerenone.</description>
      <arm_group_label>Finerenone plus empagliflozin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Empagliflozin</intervention_name>
      <description>Oral empagliflozin.</description>
      <arm_group_label>Finerenone plus empagliflozin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provide electronic or written informed consent, either personally or through a legally&#xD;
               authorized representative&#xD;
  &#xD;
            -  Age ≥18 years or legal age of majority&#xD;
  &#xD;
            -  Current hospitalization or recently discharged with the primary diagnosis of heart&#xD;
               failure&#xD;
  &#xD;
            -  Heart failure signs and symptoms at the time of hospital admission&#xD;
  &#xD;
            -  Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type&#xD;
               natriuretic peptide (BNP) ≥250 pg/mL according to the local lab for patients in sinus&#xD;
               rhythm; or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with atrial&#xD;
               fibrillation (AF), measured during the current hospitalization or in the 72 hours&#xD;
               prior to hospital admission&#xD;
  &#xD;
            -  Fulfillment of protocol defined stabilization criteria (if randomized during&#xD;
               hospitalization)&#xD;
  &#xD;
            -  Treatment during the index hospitalization with at least 1 intravenous dose of a loop&#xD;
               diuretic (e.g., furosemide, torsemide, bumetanide).&#xD;
  &#xD;
            -  Negative pregnancy test and agreement to use adequate contraception during trial&#xD;
               (female participants only)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis&#xD;
  &#xD;
            -  Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i&#xD;
  &#xD;
            -  Estimated glomerular filtration rate (eGFR) &lt;30 mL/min/1.73m² and/or serum/plasma&#xD;
               potassium &gt;5.0 mmol/L&#xD;
  &#xD;
            -  Type 1 acute myocardial infarction, coronary revascularization, valve&#xD;
               replacement/repair, or implantation of a cardiac resynchronization therapy device&#xD;
               within 30 days&#xD;
  &#xD;
            -  Prior or planned heart transplant&#xD;
  &#xD;
            -  Hemodynamically significant uncorrected primary cardiac valvular disease as primary&#xD;
               cause of heart failure&#xD;
  &#xD;
            -  Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases,&#xD;
               accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes,&#xD;
               known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or&#xD;
               pericardial constriction&#xD;
  &#xD;
            -  Probable alternative cause of participant's heart failure symptoms&#xD;
  &#xD;
            -  Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4)&#xD;
               inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers&#xD;
  &#xD;
            -  Any other condition or therapy which would make the patient unsuitable for this study&#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_contact>
      <last_name>Marc Bonaca</last_name>
      <phone>(303) 860-9900</phone>
      <email>info@cpcmed.org</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Heart Failure</keyword>
    <keyword>Hospitalized</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Empagliflozin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No current plan to share individual patient data with other researchers.</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/NCT06024746
  org study id: 202303CPC
  nct id: NCT06024746
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  Combination therapy with finerenone with empagliflozin will be compared to usual care to
        determine the efficacy and safety of treatment in patients hospitalized with heart failure.
  This is an international, randomized, controlled, open-label, trial of an early, intensive
        management strategy using the combination of finerenone plus sodium-glucose co-transporter 2
        inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Clinical benefit
  time frame: 6 months
  description: Hierarchical composite of the following assessed by the win-ratio:
  Time to death from any cause
  Number of HF events
  Time to first HF event
  Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)
  measure: Number of serious adverse events (AEs).
  time frame: 6 months
  description: - Serious AEs (excluding efficacy endpoints).
  measure: Number of adverse events leading to discontinuation of study drug.
  time frame: 6 months
  description: - AEs leading to discontinuation of finerenone or empagliflozin.
  measure: Number of deaths from any cause and total HF events.
  time frame: 6 months
  description: - All-cause mortality and total HF events (first and recurrent).
  measure: Change from baseline in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
  time frame: 6 months
  measure: Number of HF events at Day 90.
  time frame: 90 days
  description: - Total (first and recurrent) HF events.
  arm group label: Finerenone plus empagliflozin
  arm group type: Experimental
  arm group label: Usual care
  arm group type: No Intervention
  description: Usual care management
  intervention type: Drug
  intervention name: Finerenone
  description: Oral finerenone.
  arm group label: Finerenone plus empagliflozin
  intervention type: Drug
  intervention name: Empagliflozin
  description: Oral empagliflozin.
  arm group label: Finerenone plus empagliflozin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marc Bonaca
  phone: (303) 860-9900
  email: info@cpcmed.org
  responsible party type: Sponsor
  mesh term: Heart Failure
  mesh term: Empagliflozin
  sharing ipd: No
  ipd description: No current plan to share individual patient data with other researchers.