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/NCT06003972</url>
    </required_header>
    <id_info>
      <org_study_id>093418-HMO-CTIL</org_study_id>
      <nct_id>NCT06003972</nct_id>
    </id_info>
    <brief_title>Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure</brief_title>
    <acronym>Copaxone</acronym>
    <official_title>Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hadassah Medical Organization</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Weizmann Institute of Science</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hadassah Medical Organization</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute&#xD;
        decompensated heart failure.&#xD;
  &#xD;
        Trial Design&#xD;
  &#xD;
          -  An open-label, randomized, prospective trial of patients hospitalized due to acute&#xD;
             decompensation of heart failure with reduced ejection fraction.&#xD;
  &#xD;
          -  Patients will be enrolled within 24 hours from hospital admission.&#xD;
  &#xD;
          -  Randomization and intervention will begin within 24 hours of enrollment (and at least 24&#xD;
             hours after admission).&#xD;
  &#xD;
          -  Patients will be randomized in a 1:1 ratio either to receive guideline directed medical&#xD;
             therapy (GDMT) or GDMT plus Copaxone.&#xD;
  &#xD;
          -  Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14&#xD;
             days.&#xD;
  &#xD;
          -  Patients will be assessed during 4 time points(screening/randomization, visit 3 day,&#xD;
             visit 14 day, visit 30 day) as elaborated in article &quot;monitoring&quot;.&#xD;
  &#xD;
          -  Changes in inflammatory cytokines will be compared between control and intervention&#xD;
             group throughout 3 time points.&#xD;
  &#xD;
          -  The trial will be approved by the institutional view board and conducted in accordance&#xD;
             with the principles or Good Clinical Practice guidelines and the Declaration of&#xD;
             Helsinki.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 4, 2021</start_date>
    <completion_date type="Actual">March 12, 2023</completion_date>
    <primary_completion_date type="Actual">March 12, 2023</primary_completion_date>
    <phase>Phase 2</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>Primary Endpoint</measure>
      <time_frame>3 weeks</time_frame>
      <description>%change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Acute Decompensated Heart Failure</condition>
    <condition>Cytokine Storm</condition>
    <condition>Inflammatory Response</condition>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm serves as the control arm, patients allocated receive guideline directed medical therapy only</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Copaxone arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive guideline directed medical therapy with an add-on GA therapy for 14 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Copaxone</intervention_name>
      <description>Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days</description>
      <arm_group_label>Copaxone arm</arm_group_label>
      <other_name>Glatiramer Acetate</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>guideline directed medical therapy (GDMT)</intervention_name>
      <description>GDMT for heart failure according to the AHA guidelines.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  STAGE CHF BASELINE NYHA functional class II-III and established diagnosis of ischemic&#xD;
               cardiomyopathy&#xD;
  &#xD;
            -  Hospitalization due to acute decompensated CHF&#xD;
  &#xD;
            -  GDMT for at least 3 months prior to enrollment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current hospitalization:&#xD;
  &#xD;
            -  Hemodynamic instability necessitating inotropic or mechanical circulatory support&#xD;
  &#xD;
            -  Respiratory failure necessitating invasive mechanical ventilation&#xD;
  &#xD;
            -  Active infection&#xD;
  &#xD;
            -  A different etiology to explain SIRS other than CHF exacerbation.&#xD;
  &#xD;
          Prior hospitalizations or need of intravenous diuretic therapy in the last 30 days before&#xD;
          current hospitalization&#xD;
  &#xD;
          Cardiac co-morbidities:&#xD;
  &#xD;
          Specific HF etiologies:&#xD;
  &#xD;
            -  Pericardial disease&#xD;
  &#xD;
            -  Infiltrative myocardial disease&#xD;
  &#xD;
            -  Moderate and above Valvular heart disease Acute coronary syndrome in the preceding 60&#xD;
               days to randomization Evidence of significant cardiac ischemia within 1 year of&#xD;
               randomization without revascularization since Stroke or TIA in the preceding 30 days&#xD;
               from randomization&#xD;
  &#xD;
          Complex congenital cardiac defect&#xD;
  &#xD;
          New initiation of cardiac resynchronization therapy within 60 days prior to randomization&#xD;
  &#xD;
          Life threatening arrhythmias /ICD ACTIVATION- in last 90 days Listing for heart&#xD;
          transplantation or anticipated/implanted ventricular assist device&#xD;
  &#xD;
          Non-cardiac co-morbidities:&#xD;
  &#xD;
            -  Glomerular filtration rate &lt;30 mL/min/1.73m2 calculated by MDRD formula&#xD;
  &#xD;
            -  Hepatic insufficiency classified as Child-Pugh B or C&#xD;
  &#xD;
            -  SBP &gt;180 mm Hg or &lt;110 mm Hg NOT RESPONSIVE TO THERAPY&#xD;
  &#xD;
            -  Morbid obesity with a BMI &gt;40 kg/m2&#xD;
  &#xD;
            -  Severe pulmonary disease with requirement of home oxygen therapy or important&#xD;
               nocturnal desaturation&#xD;
  &#xD;
            -  Active treatment for malignancy in the past 2 years or neoplastic spread beyond organ&#xD;
               of origin (lymphatic metastases included)&#xD;
  &#xD;
            -  Hemoglobin &lt;8 g/dL&#xD;
  &#xD;
            -  Known previous systemic inflammatory disease&#xD;
  &#xD;
            -  Alcohol or drug abuse Chronic treatment with Copaxone, cytotoxic, immunosuppressant or&#xD;
               biological treatment in the past two years.&#xD;
  &#xD;
          Known Pregnancy Incapability of signing IC due to cognitive or mental reason Poor&#xD;
          compliance to medical therapy or inability to complete the study Age &gt;80 years&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Offer Amir, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Hadassah Medical Centre</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hadassah Ein Kerem medical center-hospital ,Cardiology Department</name>
        <address>
          <city>Jerusalem</city>
          <zip>911002</zip>
          <country>Israel</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
      <investigator_full_name>RABEA ASLEH</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Cytokine Release Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glatiramer Acetate</mesh_term>
      <mesh_term>(T,G)-A-L</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </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/NCT06003972
  org study id: 093418-HMO-CTIL
  nct id: NCT06003972
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute
        decompensated heart failure.
  
        Trial Design
  
          -  An open-label, randomized, prospective trial of patients hospitalized due to acute
             decompensation of heart failure with reduced ejection fraction.
  
          -  Patients will be enrolled within 24 hours from hospital admission.
  
          -  Randomization and intervention will begin within 24 hours of enrollment (and at least 24
             hours after admission).
  
          -  Patients will be randomized in a 1:1 ratio either to receive guideline directed medical
             therapy (GDMT) or GDMT plus Copaxone.
  
          -  Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14
             days.
  
          -  Patients will be assessed during 4 time points(screening/randomization, visit 3 day,
             visit 14 day, visit 30 day) as elaborated in article "monitoring".
  
          -  Changes in inflammatory cytokines will be compared between control and intervention
             group throughout 3 time points.
  
          -  The trial will be approved by the institutional view board and conducted in accordance
             with the principles or Good Clinical Practice guidelines and the Declaration of
             Helsinki.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary Endpoint
  time frame: 3 weeks
  description: %change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups
  arm group label: Control
  arm group type: Active Comparator
  description: This arm serves as the control arm, patients allocated receive guideline directed medical therapy only
  arm group label: Copaxone arm
  arm group type: Experimental
  description: Patients receive guideline directed medical therapy with an add-on GA therapy for 14 days
  intervention type: Drug
  intervention name: Copaxone
  description: Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days
  arm group label: Copaxone arm
  other name: Glatiramer Acetate
  intervention type: Drug
  intervention name: guideline directed medical therapy (GDMT)
  description: GDMT for heart failure according to the AHA guidelines.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Offer Amir, PhD
  role: Study Director
  affiliation: Hadassah Medical Centre
  facility: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Hadassah Medical Organization
  investigator full name: RABEA ASLEH
  investigator title: Professor
  mesh term: Heart Failure
  mesh term: Cytokine Release Syndrome
  mesh term: Glatiramer Acetate
  mesh term: (T,G)-A-L
  sharing ipd: Yes
  ipd info type: Study Protocol