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/NCT06033950</url>
    </required_header>
    <id_info>
      <org_study_id>202304CPC</org_study_id>
      <nct_id>NCT06033950</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists</brief_title>
    <acronym>FINALITY-HF</acronym>
    <official_title>A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-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>
        Finerenone will be compared to placebo to determine efficacy and safety of treatment in&#xD;
        patients heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible&#xD;
        to receive treatment with steroidal mineralocorticoid receptor antagonist (sMRA).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an international, randomized, double-blind, placebo-controlled trial of finerenone&#xD;
        for the treatment of heart failure patients with reduced ejection fraction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">June 2024</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2026</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to first occurrence of cardiovascular (CV) death or HF event.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>- Time to first CV death or HF event with finerenone compared to placebo.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of serious adverse events</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of adverse events leading to discontinuation of study drug.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Timing and occurrence of total HF events and CV deaths.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>- Timing and occurrence of total (first and subsequent) HF events and CV deaths with finerenone compared to placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Day 180.</measure>
      <time_frame>180 days</time_frame>
      <description>- Change in KCCQ-TSS with finerenone compared to placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first occurrence of composite kidney endpoint.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>Composite endpoint:&#xD;
  Estimated glomerular filtration rate (eGFR) ≥50% relative to baseline over at least 4 weeks, or sustained eGFR decline to &lt;15 ml/min/1.73 m2 or the initiation of long-term dialysis or kidney transplantation with finerenone compared to placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to CV death.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>- Time to CV death with finerenone compared to placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to death from any cause.</measure>
      <time_frame>Ongoing, up to ~30 months</time_frame>
      <description>- Time to all-cause mortality with finerenone compared to placebo.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">3120</enrollment>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Finerenone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Finerenone</intervention_name>
      <description>Oral finerenone.</description>
      <arm_group_label>Finerenone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching oral placebo.</description>
      <arm_group_label>Placebo</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;
            -  Symptomatic HFrEF per protocol defined criteria&#xD;
  &#xD;
            -  Not on sMRA due to history of intolerance, contraindication, or ineligibility for&#xD;
               treatment&#xD;
  &#xD;
            -  Negative pregnancy test and agreement to use adequate contraception during trial&#xD;
               (female participants only)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Treatment with non-steroidal MRA (nsMRA)&#xD;
  &#xD;
            -  eGFR &lt; 25 mL/min/1.73m² and / or serum/plasma 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 or planned&#xD;
  &#xD;
            -  Prior or planned heart transplant&#xD;
  &#xD;
            -  Hemodynamically significant (severe) uncorrected primary cardiac valvular disease&#xD;
               considered by the investigator to be the primary cause of heart failure&#xD;
  &#xD;
            -  Symptomatic bradycardia or second- or third-degree heart block without a pacemaker&#xD;
  &#xD;
            -  Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases,&#xD;
               accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes,&#xD;
               hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or&#xD;
               pericardial constriction&#xD;
  &#xD;
            -  Probable alternative cause of participant's HF&#xD;
  &#xD;
            -  Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4)&#xD;
               inhibitors, or moderate or potent CYP3A4 inducers&#xD;
  &#xD;
            -  Any other condition or therapy which would make the participant unsuitable for the&#xD;
               study&#xD;
  &#xD;
            -  Concurrent participation in another interventional clinical study using an&#xD;
               investigational agent&#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>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Reduced ejection fraction</keyword>
    <keyword>Symptomatic heart failure</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/NCT06033950
  org study id: 202304CPC
  nct id: NCT06033950
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  Finerenone will be compared to placebo to determine efficacy and safety of treatment in
        patients heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible
        to receive treatment with steroidal mineralocorticoid receptor antagonist (sMRA).
  This is an international, randomized, double-blind, placebo-controlled trial of finerenone
        for the treatment of heart failure patients with reduced ejection fraction.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Time to first occurrence of cardiovascular (CV) death or HF event.
  time frame: Ongoing, up to ~30 months
  description: - Time to first CV death or HF event with finerenone compared to placebo.
  measure: Number of serious adverse events
  time frame: Ongoing, up to ~30 months
  description: - Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
  measure: Number of adverse events leading to discontinuation of study drug.
  time frame: Ongoing, up to ~30 months
  description: - Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
  measure: Timing and occurrence of total HF events and CV deaths.
  time frame: Ongoing, up to ~30 months
  description: - Timing and occurrence of total (first and subsequent) HF events and CV deaths with finerenone compared to placebo.
  measure: Change in Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Day 180.
  time frame: 180 days
  description: - Change in KCCQ-TSS with finerenone compared to placebo.
  measure: Time to first occurrence of composite kidney endpoint.
  time frame: Ongoing, up to ~30 months
  description: Composite endpoint:
  Estimated glomerular filtration rate (eGFR) ≥50% relative to baseline over at least 4 weeks, or sustained eGFR decline to <15 ml/min/1.73 m2 or the initiation of long-term dialysis or kidney transplantation with finerenone compared to placebo.
  measure: Time to CV death.
  time frame: Ongoing, up to ~30 months
  description: - Time to CV death with finerenone compared to placebo.
  measure: Time to death from any cause.
  time frame: Ongoing, up to ~30 months
  description: - Time to all-cause mortality with finerenone compared to placebo.
  arm group label: Finerenone
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Finerenone
  description: Oral finerenone.
  arm group label: Finerenone
  intervention type: Drug
  intervention name: Placebo
  description: Matching oral placebo.
  arm group label: Placebo
  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