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/NCT05992116</url>
    </required_header>
    <id_info>
      <org_study_id>RT.IrnDefHFrEF.Jo001</org_study_id>
      <nct_id>NCT05992116</nct_id>
    </id_info>
    <brief_title>Iron Deficiency in Patients With Heart Failure and Reduced Evection Fraction</brief_title>
    <official_title>The Prevalence of Iron Deficiency in Patients With Heart Failure and Reduced Evection Fraction in a Middle Eastern Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jordan Collaborating Cardiology Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jordan Collaborating Cardiology Group</source>
    <oversight_info>
      <has_dmc>No</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>
        About half of patients with heart failure and reduced ejection fraction (HFrEF) have iron&#xD;
        deficiency who are symptomatic. This is independently associated with bad quality of life,&#xD;
        low functional capacity, lower quality of, life and increased mortality. The prevalence of&#xD;
        iron deficiency in HFrEF patients in Jordan has not been studied in the past.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The prevalence of chronic heart failure among the industrialized countries is 1-3%, and can&#xD;
        exceed 30% in the elderly population. As the population ages, there is an increase in the&#xD;
        number of co-morbidities among heart failure patients. These comorbidities are associated&#xD;
        with an increase in major adverse cardiac events (MACE), cost, and complexity of care. Iron&#xD;
        deficiency is one of the most common comorbidities occurring in patients with heart failure.&#xD;
        Its prevalence can be as high as 59%, even if patients are non-anemic[4]. Iron deficiency in&#xD;
        heart failure can lead to an impaired exercise capacity, a decreased quality of life and an&#xD;
        increased risk of hospitalizations and mortality regardless of anemia. The relationship&#xD;
        between the severity of iron deficiency and the prognosis is a linear one, with increased&#xD;
        severity being associated with increased mortality.&#xD;
  &#xD;
        Intravenous iron treatment has been shown to improve the quality of life, with an increased&#xD;
        exercise capacity and a reduced risk for hospitalizations. The prevalence of iron deficiency&#xD;
        in HFrEF patients in Middle Eastern population has not been studied. We suspect a higher&#xD;
        prevalence compared to Western populations especially in women.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Iron deficiency</measure>
      <time_frame>From date of study enrollment until the date of first documented diagnosis of iron deficiency up to 2 weeks.</time_frame>
      <description>A serum ferritin level of &lt;100 ng/ml, or a serum ferritin level of 100-299 ng/ml with a TSAT of &lt; 20% confirms the diagnosis of iron deficiency, regardless of the HB level. TSAT is calculated by the following formula: Serum iron/ TIBC *100.</description>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Iron Deficiency</condition>
    <condition>Heart Failure With Reduced Ejection Fraction</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All comers who are adults (18 years of age or older) who have heart failure with reduced&#xD;
          ejection fraction.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Heart failure with an ejection fraction of ≤40% within the last 2 years.&#xD;
  &#xD;
            -  NYHA class II-IV.&#xD;
  &#xD;
            -  NT-ProBNP &gt;125 pg/ml or BNP ≥35 pg/mL&#xD;
  &#xD;
            -  Able and willing to provide oral informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age&lt;18 years.&#xD;
  &#xD;
            -  Estimated glomerular filtration rate eGFR &lt;15 mL/min/1.73 m2.&#xD;
  &#xD;
            -  Acute coronary syndrome.&#xD;
  &#xD;
            -  Known cases of iron overload (e.g. hemochromatosis); known cases of anemia due to&#xD;
               other causes.&#xD;
  &#xD;
            -  Oral iron supplements within the previous 4 weeks; erythropoietin stimulating agents&#xD;
               or blood transfusion within the last 3 months.&#xD;
  &#xD;
            -  Active clinically relevant bleeding in the investigator's opinion.&#xD;
  &#xD;
            -  Patients with chronic inflammatory conditions (e.g. rheumatoid arthritis; Crohn's&#xD;
               disease, etc.); active infection; and decompensated liver disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Nada Hajjaj, MD</last_name>
      <role>Study Director</role>
      <affiliation>Abdali Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ramzi Tabbalat, MD, FACC</last_name>
      <phone>00962795535522</phone>
      <email>ramzi_md@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ahmad Alkhatib, MD</last_name>
      <phone>0096265109999</phone>
      <email>ramzi.tabbalat@abdalimedical.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Abdali Hospital</name>
        <address>
          <city>Amman</city>
          <zip>11145</zip>
          <country>Jordan</country>
        </address>
      </facility>
      <contact>
        <last_name>Ramzi Tabbalat, MD FACC</last_name>
        <phone>00962795525522</phone>
        <email>ramzi_md@yahoo.com</email>
      </contact>
      <contact_backup>
        <last_name>Ahmad Alkhatib, MD</last_name>
        <phone>0096265109999</phone>
        <email>ramzi.tabbalat@abdalimedical.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Iron deficiency</keyword>
    <keyword>Heart failure</keyword>
    <keyword>Heart failure with reduced ejection fraction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Anemia, Iron-Deficiency</mesh_term>
      <mesh_term>Iron Deficiencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Emails and via WhatsApp group to local cardiologists to introc=duce the study to them</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>After clinicaltrials.gov sends us an identifier number</ipd_time_frame>
    </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/NCT05992116
  org study id: RT.IrnDefHFrEF.Jo001
  nct id: NCT05992116
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  About half of patients with heart failure and reduced ejection fraction (HFrEF) have iron
        deficiency who are symptomatic. This is independently associated with bad quality of life,
        low functional capacity, lower quality of, life and increased mortality. The prevalence of
        iron deficiency in HFrEF patients in Jordan has not been studied in the past.
  The prevalence of chronic heart failure among the industrialized countries is 1-3%, and can
        exceed 30% in the elderly population. As the population ages, there is an increase in the
        number of co-morbidities among heart failure patients. These comorbidities are associated
        with an increase in major adverse cardiac events (MACE), cost, and complexity of care. Iron
        deficiency is one of the most common comorbidities occurring in patients with heart failure.
        Its prevalence can be as high as 59%, even if patients are non-anemic[4]. Iron deficiency in
        heart failure can lead to an impaired exercise capacity, a decreased quality of life and an
        increased risk of hospitalizations and mortality regardless of anemia. The relationship
        between the severity of iron deficiency and the prognosis is a linear one, with increased
        severity being associated with increased mortality.
  
        Intravenous iron treatment has been shown to improve the quality of life, with an increased
        exercise capacity and a reduced risk for hospitalizations. The prevalence of iron deficiency
        in HFrEF patients in Middle Eastern population has not been studied. We suspect a higher
        prevalence compared to Western populations especially in women.
  observational model: Case-Only
  time perspective: Prospective
  measure: Iron deficiency
  time frame: From date of study enrollment until the date of first documented diagnosis of iron deficiency up to 2 weeks.
  description: A serum ferritin level of <100 ng/ml, or a serum ferritin level of 100-299 ng/ml with a TSAT of < 20% confirms the diagnosis of iron deficiency, regardless of the HB level. TSAT is calculated by the following formula: Serum iron/ TIBC *100.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Nada Hajjaj, MD
  role: Study Director
  affiliation: Abdali Hospital
  last name: Ramzi Tabbalat, MD, FACC
  phone: 00962795535522
  email: ramzi_md@yahoo.com
  last name: Ahmad Alkhatib, MD
  phone: 0096265109999
  email: ramzi.tabbalat@abdalimedical.com
  facility: 
  contact: 
  contact backup: 
  country: Jordan
  responsible party type: Sponsor
  mesh term: Heart Failure
  mesh term: Anemia, Iron-Deficiency
  mesh term: Iron Deficiencies
  sharing ipd: Yes
  ipd description: Emails and via WhatsApp group to local cardiologists to introc=duce the study to them
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: After clinicaltrials.gov sends us an identifier number