<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/NCT03036462</url>
  </required_header>
  <id_info>
    <org_study_id>FAIR-HF2</org_study_id>
    <secondary_id>FAIR-HF2-DZHK5</secondary_id>
    <nct_id>NCT03036462</nct_id>
  </id_info>
  <brief_title>Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity &amp; Mortality</brief_title>
  <acronym>FAIR-HF2</acronym>
  <official_title>Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity &amp; Mortality - FAIR-HF2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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>
      The purpose of this study is to determine whether intravenous iron supplementation using&#xD;
      ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron&#xD;
      deficiency and heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical trial is designed as an international, prospective, multi-centre, double-blind,&#xD;
      parallel group, randomised, controlled, interventional trial to investigate whether a&#xD;
      long-term therapy with i.v. iron (ferric carboxymaltosis) compared to placebo can reduce the&#xD;
      rate of recurrent heart failure hospitalisations and cardiovascular (CV) death in patients&#xD;
      with heart failure with reduced ejection fraction (HFrEF).&#xD;
&#xD;
      I.v. iron administration in the form of ferric carboxymaltosis (FCM) will be carried out&#xD;
      according to the Summary of Product Characteristics (SmPC). Bolus administration (1000 mg)&#xD;
      will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to&#xD;
      a total of 2000 mg which is in-label) according to approved dosing rules, followed by&#xD;
      administration of 500 mg FCM at every 4 months, except when haemoglobin is &gt; 16.0 g/dL or&#xD;
      ferritin is &gt; 800 µg/L.&#xD;
&#xD;
      In the verum group, all patients will receive a saline administration, when no iron is&#xD;
      indicated at the time of the visit and according to the values listed above. Patients&#xD;
      originally assigned to the placebo group will receive a saline administration at all visits.&#xD;
&#xD;
      In the control group i.v. NaCl at a volume according to the dosing rules for FCM at all&#xD;
      visits will be administered in a double-blind manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Combined rate of recurrent hospitalisations for heart failure (HF) and of cardiovascular death (number of events)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Combined rate of recurrent hospitalisations for heart failure and of cardiovascular death during follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death (number of events)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined rate of recurrent hospitalisations for any reason and of cardiovascular death (number of events)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Combined rate of recurrent hospitalisations for any reason and of cardiovascular death during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of recurrent cardiovascular hospitalisations (number of events)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Rate of recurrent cardiovascular hospitalisations during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of recurrent HF hospitalisations (number of events)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Rate of recurrent HF hospitalisations during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of recurrent hospitalisations of any kind (number of events)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Rate of recurrent hospitalisations of any kind during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality (number of events)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>All-cause mortality during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiovascular mortality (number of events)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>cardiovascular mortality during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in NYHA (New York Heart Association) functional class (scale)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Changes in NYHA functional class during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 6-minute walk-test (nomogram)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Changes in 6-minute walk-test during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in EQ-5D (questionnaire)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Changes EQ-5D during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Patient Global Assessment (PGA) of wellbeing (questionnaire)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Changes in PGA of wellbeing during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in renal parameters (laboratory parameters)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Changes in renal from baseline to end of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cardiovascular parameters (laboratory parameters)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Changes in cardiovascular parameters from baseline to end of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in inflammatory parameters (laboratory parameters)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Changes in inflammatory parameters from baseline to end of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in metabolic parameters (laboratory parameters)</measure>
    <time_frame>for a minimum average follow-up of &gt;2 years (We aim for a minimum follow-up of 6 months for all patients)</time_frame>
    <description>Changes in metabolic parameters from baseline to end of follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Systolic Heart Failure</condition>
  <condition>Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>Verum group (FCM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I.v. iron administration in the form of FCM will be carried out according to SmPC. I.v. iron bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks, (up to a total of 2000 mg which is in-label), according to the approved dosing rules, followed by administration of 500 mg FCM at every 4 months, except when haemoglobin is &gt; 16.0 g/dL or ferritin is &gt; 800 µg/L .In the verum group, all patients will receive a saline administration, when no iron is indicated at the time of the visit and according to the values listed above.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group (NaCL)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of i.v. NaCl at a volume according to the dosing rules for FCM, i.e. as described for the verum group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron</intervention_name>
    <description>i.v. iron administration</description>
    <arm_group_label>Verum group (FCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>i.v. NaCl administration</description>
    <arm_group_label>Placebo group (NaCL)</arm_group_label>
    <other_name>salin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of&#xD;
             documented LVEF&lt;45%.&#xD;
&#xD;
          2. Confirmed presence of ID (ferritin &lt; 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT &lt;&#xD;
             20 %)&#xD;
&#xD;
          3. Serum haemoglobin of 9.5 - 14.0 g/dL&#xD;
&#xD;
          4. At time of screening considered re-stabilised and planned for discharge within next 24&#xD;
             h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12 months&#xD;
             (NYHA 2-4), or stable ambulatory with BNP &gt; 100 pg/mL or NT-proBNP &gt; 300 pg/mL or&#xD;
             MR-proANP &gt; 120 pmol/L (NYHA 2-4)&#xD;
&#xD;
          5. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to the active substance, to FCM or any of its excipients&#xD;
&#xD;
          2. Known serious hypersensitivity to other parenteral iron products&#xD;
&#xD;
          3. Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia&#xD;
&#xD;
          4. Evidence of iron overload or disturbances in the utilisation of iron&#xD;
&#xD;
          5. History of severe asthma with known FEV1 &lt;50%&#xD;
&#xD;
          6. Acute bacterial infection&#xD;
&#xD;
          7. Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs&#xD;
             to be corrected first)&#xD;
&#xD;
          8. Use of renal replacement therapy&#xD;
&#xD;
          9. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood&#xD;
             transfusion in the previous 6 weeks prior to randomisation.&#xD;
&#xD;
         10. More than 500 meters in the initial 6-minutes walking-test&#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_official>
    <last_name>Mahir Karaks, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahir Karakas, MD</last_name>
    <phone>0049 407410</phone>
    <phone_ext>57975</phone_ext>
    <email>m.karakas@uke.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stefan Anker, MD</last_name>
    <email>s.anker@cachexia.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald</name>
      <address>
        <city>Bad Friedrichshall</city>
        <zip>74177</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas J Dengler, Dr. med.</last_name>
      <email>Thomas.Dengler@slk-kliniken.de</email>
    </contact>
    <contact_backup>
      <last_name>Cornelia Neatu, Dr. med.</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Kerckhoff Klinik Bad Nauheim</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian W Hamm, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Rankestrasse</name>
      <address>
        <city>Berlin</city>
        <zip>10789</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Berlin Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David M Leistner, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Charité Berlin (Campus Virchow-Klinikum)</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank Edelmann, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stiftung Bremer Herzen Bremer Institut für Herz- und Kreislauf- Forschung</name>
      <address>
        <city>Bremen</city>
        <zip>28277</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harm Wienbergen, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Dresden, Universitätsklinik</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniklinik Greifswald, Klinik und Poliklinik für Innere Medizin B</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Beug, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephan von Haehling, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle (Saale)</name>
      <address>
        <city>Halle</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitärsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahir Karakas, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cardiologicum Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>22041</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina Paitazoglou, Dr. med.</last_name>
      <email>C.Paitazoglou@cardiologicum.net</email>
    </contact>
    <contact_backup>
      <last_name>Annette Schmidt</last_name>
      <email>A.Schmidt@cardiologicum.net</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lutz Frankenstein, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ingrid Kindermann, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena, Kardiologie</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tarek Bekfani, Dr. med.</last_name>
      <email>Tarek.Bekfani@med.uni-jena.de</email>
    </contact>
    <contact_backup>
      <last_name>Paul Christian Schulze, Prof</last_name>
      <email>'Christian.Schulze@med.uni-jena.de'</email>
    </contact_backup>
    <investigator>
      <last_name>Tarek Bekfani, Dr.med</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Luedde, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein Campus Lübeck</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tobias Graf, MD</last_name>
    </contact>
    <investigator>
      <last_name>Tobias Graf, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Schmeißer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tommaso Gori, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina Dösch, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie</name>
      <address>
        <city>Mönchengladbach</city>
        <zip>41063</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Schön Mühldorf</name>
      <address>
        <city>Mühldorf</city>
        <zip>84453</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>LMU München Medizinische Klinik und Poliklinik 1</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Kääb, Prof. Dr.</last_name>
    </contact>
    <investigator>
      <last_name>Stefan Kääb, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar I. Medizinische Klinik und Poliklinik</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Hagenmiller/ Jeserich</name>
      <address>
        <city>Nürnberg</city>
        <zip>90402</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Jeserich, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Medizinische Klinik 8 - Kardiologie Paracelsus Medizinische Privatuniversität Klinikum Nürnberg, Campus Süd</name>
      <address>
        <city>Nürnberg</city>
        <zip>90471</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>KardioPrax Remscheid</name>
      <address>
        <city>Remscheid</city>
        <zip>42853</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Detlev Moll, Dr.</last_name>
    </contact>
    <investigator>
      <last_name>Detlev Moll, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kardiologische Praxis Dr. Jens Placke</name>
      <address>
        <city>Rostock</city>
        <zip>18059</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Placke, Dr. med.</last_name>
      <email>placke@telemed.de</email>
    </contact>
    <contact_backup>
      <last_name>Stephan Drawert, Dr. med.</last_name>
      <email>stephan.drawert@kliniksued-rostock.de</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Herzklinik Ulm GbR</name>
      <address>
        <city>Ulm</city>
        <zip>89077</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jochen Woehrle, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Szent Imre Kórház</name>
      <address>
        <city>Budapest</city>
        <zip>1115</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bela Merkely, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Szent János kórház és Észak-budai Egyesített kórházak</name>
      <address>
        <city>Budapest</city>
        <zip>1125</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Honvéd Kórház</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Róbert G Kiss, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pécsi Orvostudományi</name>
      <address>
        <city>Pecs</city>
        <zip>7624</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kálmán Tóth, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Almási Balogh Pál Kórház</name>
      <address>
        <city>Ózd</city>
        <zip>3600</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bélteczki János, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS San Raffaele Pisana (06-01)</name>
      <address>
        <city>Rome</city>
        <zip>00163</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maurizio Volterrani, MD</last_name>
    </contact>
    <investigator>
      <last_name>Maurizio Volterrani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cermed Hernik (05-07)</name>
      <address>
        <city>Białystok</city>
        <zip>15-270</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oddział Kardiologii Uniwersyteckiego (05-06)</name>
      <address>
        <city>Opole</city>
        <zip>45-401</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marek Gierlotka, Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Marek Gierlotka, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinika Niewydolności Serca I Transplantologii (05-04)</name>
      <address>
        <city>Warsaw</city>
        <zip>04-743</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Przemyslaw Leszek, Prof</last_name>
      <email>przemyslaw.leszek@ikard.pl</email>
    </contact>
    <investigator>
      <last_name>Przemyslaw Leszek, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wroclaw Medical University (05-01)</name>
      <address>
        <city>Warschau</city>
        <zip>50-981</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ewa Jankowska, Prof.</last_name>
      <email>ewa.jankowska@umed.wroc.pl</email>
    </contact>
    <investigator>
      <last_name>Ewa Jankowska, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>KLIMED Marek Klimkiewicz Lomza (05-05)</name>
      <address>
        <city>Łomża</city>
        <zip>18-404</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de la Luz</name>
      <address>
        <city>Lisbon</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pedro Moraes Sarmento, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Santa Maria University Hospital</name>
      <address>
        <city>Lisbon</city>
        <zip>1649-028</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dulce Brito, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Fausto Pinto, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Center Zemun</name>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aleksandar Nešković, Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Aleksandar Nešković, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Center of Serbia, Department of Cardiology</name>
      <address>
        <city>Belgrad</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Milika Asanin, Dr.</last_name>
      <email>masanin2013@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Milika Asanin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Center Zvezdara</name>
      <address>
        <city>Belgrad</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Goran Lončar</last_name>
    </contact>
    <investigator>
      <last_name>Goran Lončar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institute of Cardiovascular Diseases &quot;Dedinje&quot;</name>
      <address>
        <city>Belgrad</city>
        <zip>11040</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Petar Otašević</last_name>
    </contact>
    <investigator>
      <last_name>Petar Otašević</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>General Hospital &quot;Sveti Luka&quot;</name>
      <address>
        <city>Smederevo</city>
        <zip>11300</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Predrag Petrović</last_name>
    </contact>
    <investigator>
      <last_name>Predrag Petrović</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institute for Cardiovascular Diseases of Vojvodina</name>
      <address>
        <city>Sremska Kamenica</city>
        <zip>21204</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nada Čemerlić Ađić, Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Nada Čemerlić Ađić, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Ljubljana (07-03)</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bojan Vrtovec, Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Bojan Vrtovec, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>General Hospital Murska Sobota Division of Cardiology (07-01)</name>
      <address>
        <city>Murska Sobota</city>
        <zip>9000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mitja Lainscak, Prof</last_name>
      <email>mitja.lainscak@guest.arnes.si</email>
    </contact>
    <investigator>
      <last_name>Mitja Lainscak, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Topolšica (07-03)</name>
      <address>
        <city>Topolšica</city>
        <zip>SI-3326</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucija Gaberšček Parežnik, Dr</last_name>
      <email>Lucija.Gabrscek@b-topolsica.si</email>
    </contact>
    <investigator>
      <last_name>Lucija Gaberš Parežnik, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar (04-01)</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clinico San Carlos Madrid (04-04)</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ramon Bover, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitarion Virgen de la Victoria (04-03)</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jose M Garcia Pinilla, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Valencia (04-02)</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Julio Nuñez Villota, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital la Fe de Valencia (04-05)</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Luis Almenar Bonet, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Serbia</country>
    <country>Slovenia</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>December 28, 2022</last_update_submitted>
  <last_update_submitted_qc>December 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intravenous iron</keyword>
  <keyword>systolic heart failure</keyword>
  <keyword>iron deficiency</keyword>
  <keyword>morbidity</keyword>
  <keyword>mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Systolic</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Systolic Murmurs</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/NCT03036462
org study id: FAIR-HF2
secondary id: FAIR-HF2-DZHK5
nct id: NCT03036462
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to determine whether intravenous iron supplementation using
      ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron
      deficiency and heart failure.
The clinical trial is designed as an international, prospective, multi-centre, double-blind,
      parallel group, randomised, controlled, interventional trial to investigate whether a
      long-term therapy with i.v. iron (ferric carboxymaltosis) compared to placebo can reduce the
      rate of recurrent heart failure hospitalisations and cardiovascular (CV) death in patients
      with heart failure with reduced ejection fraction (HFrEF).

      I.v. iron administration in the form of ferric carboxymaltosis (FCM) will be carried out
      according to the Summary of Product Characteristics (SmPC). Bolus administration (1000 mg)
      will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to
      a total of 2000 mg which is in-label) according to approved dosing rules, followed by
      administration of 500 mg FCM at every 4 months, except when haemoglobin is > 16.0 g/dL or
      ferritin is > 800 µg/L.

      In the verum group, all patients will receive a saline administration, when no iron is
      indicated at the time of the visit and according to the values listed above. Patients
      originally assigned to the placebo group will receive a saline administration at all visits.

      In the control group i.v. NaCl at a volume according to the dosing rules for FCM at all
      visits will be administered in a double-blind manner.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Combined rate of recurrent hospitalisations for heart failure (HF) and of cardiovascular death (number of events)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Combined rate of recurrent hospitalisations for heart failure and of cardiovascular death during follow-up.
measure: Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death (number of events)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death during follow-up
measure: Combined rate of recurrent hospitalisations for any reason and of cardiovascular death (number of events)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Combined rate of recurrent hospitalisations for any reason and of cardiovascular death during follow-up
measure: Rate of recurrent cardiovascular hospitalisations (number of events)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Rate of recurrent cardiovascular hospitalisations during follow-up
measure: Rate of recurrent HF hospitalisations (number of events)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Rate of recurrent HF hospitalisations during follow-up
measure: Rate of recurrent hospitalisations of any kind (number of events)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Rate of recurrent hospitalisations of any kind during follow-up
measure: All-cause mortality (number of events)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: All-cause mortality during follow-up
measure: cardiovascular mortality (number of events)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: cardiovascular mortality during follow-up
measure: Changes in NYHA (New York Heart Association) functional class (scale)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Changes in NYHA functional class during follow-up
measure: Changes in 6-minute walk-test (nomogram)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Changes in 6-minute walk-test during follow-up
measure: Changes in EQ-5D (questionnaire)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Changes EQ-5D during follow-up
measure: Changes in Patient Global Assessment (PGA) of wellbeing (questionnaire)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Changes in PGA of wellbeing during follow-up
measure: Changes in renal parameters (laboratory parameters)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Changes in renal from baseline to end of follow-up
measure: Changes in cardiovascular parameters (laboratory parameters)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Changes in cardiovascular parameters from baseline to end of follow-up
measure: Changes in inflammatory parameters (laboratory parameters)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Changes in inflammatory parameters from baseline to end of follow-up
measure: Changes in metabolic parameters (laboratory parameters)
time frame: for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
description: Changes in metabolic parameters from baseline to end of follow-up
arm group label: Verum group (FCM)
arm group type: Experimental
description: I.v. iron administration in the form of FCM will be carried out according to SmPC. I.v. iron bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks, (up to a total of 2000 mg which is in-label), according to the approved dosing rules, followed by administration of 500 mg FCM at every 4 months, except when haemoglobin is > 16.0 g/dL or ferritin is > 800 µg/L .In the verum group, all patients will receive a saline administration, when no iron is indicated at the time of the visit and according to the values listed above.
arm group label: Placebo group (NaCL)
arm group type: Placebo Comparator
description: Administration of i.v. NaCl at a volume according to the dosing rules for FCM, i.e. as described for the verum group.
intervention type: Drug
intervention name: Iron
description: i.v. iron administration
arm group label: Verum group (FCM)
intervention type: Drug
intervention name: Saline
description: i.v. NaCl administration
arm group label: Placebo group (NaCL)
other name: salin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mahir Karaks, MD
role: Principal Investigator
affiliation: Universitätsklinikum Hamburg-Eppendorf
last name: Mahir Karakas, MD
phone: 0049 407410
phone ext: 57975
email: m.karakas@uke.de
last name: Stefan Anker, MD
email: s.anker@cachexia.de
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Germany
country: Hungary
country: Italy
country: Poland
country: Portugal
country: Serbia
country: Slovenia
country: Spain
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Systolic Murmurs
sharing ipd: No