<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/NCT02998697</url>
  </required_header>
  <id_info>
    <org_study_id>LB.02.01/VII/077/KEP.033EV</org_study_id>
    <nct_id>NCT02998697</nct_id>
  </id_info>
  <brief_title>Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia</brief_title>
  <acronym>IRON5</acronym>
  <official_title>The Effect of Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cardiovascular Center Harapan Kita Hospital Indonesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cardiovascular Center Harapan Kita Hospital Indonesia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in&#xD;
      improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia&#xD;
      (IDA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54&#xD;
      Heart Failure (HF) patients (LVEF &lt; 50%) with IDA (Ferritin &lt; 100 ng/mL or 100-300 ng/mL with&#xD;
      Tsat &lt; 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January&#xD;
      to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the&#xD;
      investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary&#xD;
      end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT&#xD;
      serum lactate levels as secondary end-points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 2/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>Functional Capacity</measure>
    <time_frame>90 days</time_frame>
    <description>Six Minute Walk Test (meter)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ferritin</measure>
    <time_frame>90 days</time_frame>
    <description>Ferritin level (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transferrin saturation</measure>
    <time_frame>90 days</time_frame>
    <description>Transferrin saturation (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin</measure>
    <time_frame>90 days</time_frame>
    <description>Haemoglobin level (gr/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiography parameters</measure>
    <time_frame>90 days</time_frame>
    <description>Left Ventricle Ejection Fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N Terminal-pro Brain Natriuretic Peptide</measure>
    <time_frame>90 days</time_frame>
    <description>NT-proBNP level (pg/mL)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Heart Failure, Systolic</condition>
  <condition>Iron-deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Treated Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Systolic heart failure patients received placebo oral capsule t.i.d for 90 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous Sulfate</intervention_name>
    <description>Ferrous sulfate 200 mg t.i.d for 90 days</description>
    <arm_group_label>Treated Group</arm_group_label>
    <other_name>Ferrous Sulfate oral capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>Lactose 200 mg t.i.d for 90 days</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 year old&#xD;
&#xD;
          -  Systolic heart failure patients without clinical sign of decompensation at outpatient&#xD;
             clinic&#xD;
&#xD;
          -  New York Heart Association (NYHA) functional class II-III able to perform 6MWT&#xD;
&#xD;
          -  LVEF &lt; 50%&#xD;
&#xD;
          -  On heart failure therapy&#xD;
&#xD;
          -  Haemoglobin (Hb) &lt; 13 gr/dL (male); Hb &lt; 12 gr/dL (female) and &gt; 8 gr/dL&#xD;
&#xD;
          -  Ferritin &lt; 100 µg/L or Ferritin 100-300 µg/L dengan Transferrin saturation (Tsat) &lt;&#xD;
             20%&#xD;
&#xD;
          -  Agree to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of : active bleeding,infection, malignancy, haematological abnormality, peptic&#xD;
             ulcer&#xD;
&#xD;
          -  History of myocardial revascularization (CABG/PCI) within 3 month&#xD;
&#xD;
          -  Acute Coronary Syndrome (ACS), stroke,Transient Ischemic Attack (TIA) within 3 month&#xD;
&#xD;
          -  Know to have allergic reaction to Ferrous sulfate&#xD;
&#xD;
          -  History of intravenous iron administration within 1 month&#xD;
&#xD;
          -  Permanent Pace Maker(PPM)/Implantable Cardiac Defibrillator (ICD)/Cardiac&#xD;
             Resynchronization Therapy (CRT)&#xD;
&#xD;
          -  estimated Glomerular Filtration Rate (eGFR) &lt; 30 ml/min/1.73m2&#xD;
&#xD;
          -  NT-proBNP &gt; 4000 pg/ml (for patients without baseline data) or decreased level of&#xD;
             NT-proBNP &lt; 30% from baseline&#xD;
&#xD;
          -  Increase level of serum alanine aminotransferase (ALT)/ serum aspartate&#xD;
             aminotransferase (AST)&gt; 3x normal value&#xD;
&#xD;
          -  Moderate to severe primary valvular heart disease&#xD;
&#xD;
          -  Congenital heart disease&#xD;
&#xD;
          -  Right heart failure due to primary pulmonary hypertension, cor pulmonale, Chronic&#xD;
             Thrombo-Embolic Pulmonary Hypertension (CTEPH)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bambang B Siswanto, Professor</last_name>
    <role>Study Director</role>
    <affiliation>National Cardiovascular Center Harapan Kita</affiliation>
  </overall_official>
  <results_reference>
    <citation>Niehaus ED, Malhotra R, Cocca-Spofford D, Semigran M, Lewis GD. Repletion of Iron Stores With the Use of Oral Iron Supplementation in Patients With Systolic Heart Failure. J Card Fail. 2015 Aug;21(8):694-7. doi: 10.1016/j.cardfail.2015.05.006. Epub 2015 May 29.</citation>
    <PMID>26028263</PMID>
  </results_reference>
  <results_reference>
    <citation>Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.</citation>
    <PMID>19920054</PMID>
  </results_reference>
  <results_reference>
    <citation>McDonagh T, Macdougall IC. Iron therapy for the treatment of iron deficiency in chronic heart failure: intravenous or oral? Eur J Heart Fail. 2015 Mar;17(3):248-62. doi: 10.1002/ejhf.236. Epub 2015 Jan 30.</citation>
    <PMID>25639592</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cardiovascular Center Harapan Kita Hospital Indonesia</investigator_affiliation>
    <investigator_full_name>Lita Dwi Suryani</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Systolic Heart Failure</keyword>
  <keyword>Anemia</keyword>
  <keyword>Iron Deficiency</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</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Deficiency Diseases</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/NCT02998697
org study id: LB.02.01/VII/077/KEP.033EV
nct id: NCT02998697
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in
      improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia
      (IDA).
The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54
      Heart Failure (HF) patients (LVEF < 50%) with IDA (Ferritin < 100 ng/mL or 100-300 ng/mL with
      Tsat < 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January
      to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the
      investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary
      end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT
      serum lactate levels as secondary end-points.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Functional Capacity
time frame: 90 days
description: Six Minute Walk Test (meter)
measure: Ferritin
time frame: 90 days
description: Ferritin level (ng/mL)
measure: Transferrin saturation
time frame: 90 days
description: Transferrin saturation (%)
measure: Haemoglobin
time frame: 90 days
description: Haemoglobin level (gr/dL)
measure: Echocardiography parameters
time frame: 90 days
description: Left Ventricle Ejection Fraction
measure: N Terminal-pro Brain Natriuretic Peptide
time frame: 90 days
description: NT-proBNP level (pg/mL)
arm group label: Treated Group
arm group type: Experimental
description: Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days
arm group label: Control Group
arm group type: Placebo Comparator
description: Systolic heart failure patients received placebo oral capsule t.i.d for 90 days
intervention type: Drug
intervention name: Ferrous Sulfate
description: Ferrous sulfate 200 mg t.i.d for 90 days
arm group label: Treated Group
other name: Ferrous Sulfate oral capsule
intervention type: Drug
intervention name: Placebo Oral Capsule
description: Lactose 200 mg t.i.d for 90 days
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bambang B Siswanto, Professor
role: Study Director
affiliation: National Cardiovascular Center Harapan Kita
citation: Niehaus ED, Malhotra R, Cocca-Spofford D, Semigran M, Lewis GD. Repletion of Iron Stores With the Use of Oral Iron Supplementation in Patients With Systolic Heart Failure. J Card Fail. 2015 Aug;21(8):694-7. doi: 10.1016/j.cardfail.2015.05.006. Epub 2015 May 29.
PMID: 26028263
citation: Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
PMID: 19920054
citation: McDonagh T, Macdougall IC. Iron therapy for the treatment of iron deficiency in chronic heart failure: intravenous or oral? Eur J Heart Fail. 2015 Mar;17(3):248-62. doi: 10.1002/ejhf.236. Epub 2015 Jan 30.
PMID: 25639592
responsible party type: Principal Investigator
investigator affiliation: National Cardiovascular Center Harapan Kita Hospital Indonesia
investigator full name: Lita Dwi Suryani
investigator title: Principal Investigator
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Deficiency Diseases
mesh term: Systolic Murmurs
sharing ipd: No