<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/NCT03042130</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-16-HO-512-CTIL</org_study_id>
    <nct_id>NCT03042130</nct_id>
  </id_info>
  <brief_title>Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency</brief_title>
  <official_title>Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be&#xD;
      randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The&#xD;
      control group will receive standard of care alone. The study will test for the effects of the&#xD;
      additional IV iron on the symptoms, clinical picture and quality of life of the treated&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be&#xD;
      randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The&#xD;
      control group will receive standard of care alone. The study will test for the effects of the&#xD;
      additional IV iron on the symptoms, clinical picture and quality of life of the treated&#xD;
      patients. The parameters that will be measured will include clinical, lab, echo, and quality&#xD;
      of life questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">December 14, 2016</start_date>
  <completion_date type="Actual">February 6, 2018</completion_date>
  <primary_completion_date type="Actual">February 6, 2018</primary_completion_date>
  <phase>Phase 4</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>Functioning improvement</measure>
    <time_frame>5 days after second administration</time_frame>
    <description>NYHA assesment (New York Heart Association (NYHA) Functional Classification)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life improvement</measure>
    <time_frame>5 days after second administration</time_frame>
    <description>KCCQ questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functioning improvement</measure>
    <time_frame>1 month after second administration</time_frame>
    <description>NYHA assesment (New York Heart Association (NYHA) Functional Classification)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life improvement</measure>
    <time_frame>1 month after second administration</time_frame>
    <description>KCCQ (The Kansas City Cardiomyopathy Questionnaire)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Iron Carboxymaltose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard of care + double dose of IV iron ferinject&#xD;
the medicine will be given twice within one week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>standard of care</description>
    <arm_group_label>Iron Carboxymaltose</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron Carboxymaltose</intervention_name>
    <description>Two IV doses</description>
    <arm_group_label>Iron Carboxymaltose</arm_group_label>
    <other_name>Ferinject</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heart failure grade 3-4&#xD;
&#xD;
          -  Heart echo EF&lt; 40% (ejection fraction)&#xD;
&#xD;
          -  Hb &gt; 10 mg/dL&#xD;
&#xD;
          -  Iron&gt; 50 mic/dL&#xD;
&#xD;
          -  Iron/ transferrin rate &gt; 20%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  Acute ischemia&#xD;
&#xD;
          -  Patients that didn't receive the standard of care during 3 days before investigational&#xD;
             product administration&#xD;
&#xD;
          -  Hemochromatosis&#xD;
&#xD;
          -  Known allergy to one of the products of the investigational product.&#xD;
&#xD;
          -  Macrocytic anemia&#xD;
&#xD;
          -  Iron excess&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Mentally disabled patients which can't give their concent properly.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Howard Oster, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physician - Internal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of internal medicine A</name>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 26, 2018</last_update_submitted>
  <last_update_submitted_qc>February 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</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>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03042130
org study id: TASMC-16-HO-512-CTIL
nct id: NCT03042130
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be
      randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The
      control group will receive standard of care alone. The study will test for the effects of the
      additional IV iron on the symptoms, clinical picture and quality of life of the treated
      patients.
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be
      randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The
      control group will receive standard of care alone. The study will test for the effects of the
      additional IV iron on the symptoms, clinical picture and quality of life of the treated
      patients. The parameters that will be measured will include clinical, lab, echo, and quality
      of life questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functioning improvement
time frame: 5 days after second administration
description: NYHA assesment (New York Heart Association (NYHA) Functional Classification)
measure: Quality of life improvement
time frame: 5 days after second administration
description: KCCQ questionnaires
measure: Functioning improvement
time frame: 1 month after second administration
description: NYHA assesment (New York Heart Association (NYHA) Functional Classification)
measure: Quality of life improvement
time frame: 1 month after second administration
description: KCCQ (The Kansas City Cardiomyopathy Questionnaire)
arm group label: Iron Carboxymaltose
arm group type: Experimental
description: standard of care + double dose of IV iron ferinject
the medicine will be given twice within one week.
arm group label: control
arm group type: Other
description: standard of care
intervention type: Other
intervention name: Standard of care
description: standard of care
arm group label: Iron Carboxymaltose
arm group label: control
intervention type: Drug
intervention name: Iron Carboxymaltose
description: Two IV doses
arm group label: Iron Carboxymaltose
other name: Ferinject
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Howard Oster, Dr.
role: Principal Investigator
affiliation: Physician - Internal Medicine
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Iron Deficiencies
sharing ipd: No