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/NCT05971732</url>
    </required_header>
    <id_info>
      <org_study_id>Monofer-HFrEF</org_study_id>
      <nct_id>NCT05971732</nct_id>
    </id_info>
    <brief_title>The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)</brief_title>
    <acronym>COREVIVE-HFrEF</acronym>
    <official_title>The Effects of Ferric Derisomaltose Administered Before Hospital Discharge in Stabilised Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life: a Randomised, Parallel-group, Double-blind, Placebo Controlled Trial (COREVIVE-HFrEF)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China-Japan Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China-Japan Friendship Hospital</source>
    <oversight_info>
      <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>
        This study will address whether the additional use of Ferric Derisomaltose on top of standard&#xD;
        care will improve exercise capacity and quality of life in patients with acute heart failure&#xD;
        and iron deficiency. One group of participants will receive treatment with Ferric&#xD;
        Derisomaltose and the other group will receive normal saline 0.9% as placebo.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acute heart failure (AHF) is a very common medical problem. Despite improvements in&#xD;
        treatment, many patients suffer limiting exercise capacity and quality of life. Previous&#xD;
        comorbidities may account for it. Approximately 80% of patients hospitalized with AHF&#xD;
        suffered from a combination of iron deficiency. A decline in exercise capacity may occur&#xD;
        under this condition. Some research studies have suggested that giving CHF patients&#xD;
        intravenous iron improves symptoms in the short term. It is unknown, however, whether&#xD;
        correcting iron deficiency is beneficial to patients with AHF to improve excise capacity and&#xD;
        whether it improves quality of life and accelerate recovery from acute duration. This study&#xD;
        will help us answer these key questions.&#xD;
  &#xD;
        This is an investigator-initiated, randomised, parallel group, double-blind,&#xD;
        placebo-controlled trial, evaluating the excise capacity improvement of using ferric&#xD;
        derisomaltose versus placebo in hospitalized patients with acute heart failure with reduced&#xD;
        ejection fraction before discharge.&#xD;
  &#xD;
        Participants will be assessed daily using 6-minute walking test after IV iron injection until&#xD;
        discharge from hospital, especially focus on the change from baseline to the 3rd day. Some&#xD;
        questionnaires are also conducted to evaluate the self-reported status. Participants will be&#xD;
        followed up at 2 weeks and 4 weeks.&#xD;
  &#xD;
        The primary and secondary endpoints will be examined in subgroups predefined by baseline&#xD;
        variables reflecting demography, Hb level, etiology of HF, left ventricular ejection&#xD;
        fraction, natriuretic peptide, index of iron metabolism, eGFR and others.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in 6-minute walking distance</measure>
      <time_frame>Up to 3 days</time_frame>
      <description>The difference of 6-minute walking distance in meters from baseline to day3 after IV iron injection.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in 6-minute walking distance</measure>
      <time_frame>At 2 weeks, 4weeks after IV iron injection</time_frame>
      <description>The difference of 6-minute walking distance in meters from baseline at 2 weeks, 4weeks after IV iron injection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in the KCCQ Clinical Summary Score</measure>
      <time_frame>At 2 weeks, 4weeks after IV iron injection</time_frame>
      <description>KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration.&#xD;
  The descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in NYHA Functional Class</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>NYHA = New York Heart Association&#xD;
  NYHA functional class was assessed as Class I, II, III, IV:&#xD;
  Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.&#xD;
  Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.&#xD;
  Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.&#xD;
  Class IV - Severe limitations. Experiences symptoms even while at rest.&#xD;
  Lower response categories are better for score NYHA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in PGA quality of life questionnaire</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>PGA:Patient Global Assessment&#xD;
  PGA questionnaire consists of a health descriptive system for participants to self-reported and rate their medical condition after participate this study.&#xD;
  The descriptive system includes 7 choices：has much improved, has (moderately) improved, has a little improved, is unchanged, is a little worse, is (moderately) worse, is much worse, which are coded from 1 (best state) to 7 (worst state).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Concentration of hemoglobin (Hb)</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>Hemoglobin (Hb) is a commonly used clinical test for assessing anaemia, with units of g/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in proportion of reticulocyte (Ret%)</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>The reticulocyte ratio is often used to reflect the hematopoiesis of the bone marrow erythrocyte with units of percentage(%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Concentration of ferritin</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>To assess the effect of ferric derisomaltose vs. placebo on change in ferritin from baseline to 3 days, 2weeks and 4weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in concentration of transferrin saturation</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>To assess the effect of ferric derisomaltose vs. placebo on change in transferrin saturation from baseline to 3 days, 2weeks and 4weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Concentration of serum transferrin receptors (sTfR)</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>To assess the effect of ferric derisomaltose vs. placebo on change in serum transferrin receptors (sTfR) from baseline to 3 days, 2weeks and 4weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>To assess the effect of ferric derisomaltose vs. placebo on change in NT-proBNP from baseline to 3 days, 2weeks and 4weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Left Ventricular Systolic Function</measure>
      <time_frame>At 2weeks, 4weeks after IV iron injection</time_frame>
      <description>Left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Left Ventricular End-Diastolic Diameter</measure>
      <time_frame>At 2weeks, 4weeks after IV iron injection</time_frame>
      <description>Left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR)</measure>
      <time_frame>At 3 days, 2weeks, 4weeks after IV iron injection</time_frame>
      <description>Urine Albumin-to-Creatinine Ratio (UACR) is regard as a safety endpoint to reflect early injury of kidney.</description>
    </other_outcome>
    <other_outcome>
      <measure>A rise of high-sensitivity C-reaction protein (hs-CRP) levels from baseline</measure>
      <time_frame>Up to 4weeks</time_frame>
      <description>Safety endpoint is defined as a rise of high-sensitivity C-reaction protein (hs-CRP) from baseline.</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse Event after IV iron injection</measure>
      <time_frame>Up to 4weeks</time_frame>
      <description>Adverse Event Include Fishbane symptoms (flushing/chest pain/back pain/chest tightness, sometimes with dyspnea), isolated signs and symptoms (urticaria/pruritus/rash/mild hypotension, hypertension/tachycardia/nausea/headache), signs and symptoms of allergic reactions (persistent hypotension; airway angioedema/generalised urticaria, non-airway angioedema/wheezing, bronchospasm, vomiting, abdominal pain, etc.)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">146</enrollment>
    <condition>Heart Failure With Reduced Ejection Fraction</condition>
    <condition>Iron Deficiency</condition>
    <condition>Acute Heart Failure</condition>
    <arm_group>
      <arm_group_label>Ferric derisomaltose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Iron to be administered as ferric derisomaltose.&#xD;
  The treatment dose (mL) to be administered will be determined by the patient's body weight and hemoglobin (Hb) value.&#xD;
  Where Hb ≥10 g/dL, dosage according to body weight is as follows:&#xD;
  Body weight &lt;50 kg: 20 mg/kg; Body weight 50 to &lt;70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg.&#xD;
  Where Hb &lt;10 g/dL, dosage according to body weight is as follows:&#xD;
  Body weight &lt;50 kg: 20 mg/kg; Body weight 50 to &lt;70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg.&#xD;
  Infused over a minimum of 15mins for doses up to and including 1000mg, and a minimum of 30 mins for doses &gt;1000mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants in this arm will receive normal saline 0.9% in analogy to treatment arm.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ferric derisomaltose</intervention_name>
      <description>After baseline assessments patients will be randomised in a 1:1 ratio to receive ferric derisomaltose IV or placebo (normal saline). In the Treatment group, Ferric derisomaltose will be administered according to the dosing schedule.</description>
      <arm_group_label>Ferric derisomaltose</arm_group_label>
      <other_name>Monofer</other_name>
      <other_name>Iron (III) isomaltoside 1000</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>In the placebo group, patients will receive the equivalent number of normal saline injections.</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>Normal saline</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years.&#xD;
  &#xD;
            2. Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as&#xD;
               documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF)&#xD;
               &lt;50% before randomization.&#xD;
  &#xD;
            3. Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the&#xD;
               primary reason for hospitalisation, New York Heart Association (NYHA) class II - IV.&#xD;
  &#xD;
            4. Reaching hemodynamic stability after standard treatment (if tolerated, initiate four&#xD;
               pillars of guideline-directed medical therapies). All of the following (i.e., items a&#xD;
               to c) must apply:&#xD;
  &#xD;
                 1. Systolic blood pressure≥100mmHg, without symptoms of hypotension;&#xD;
  &#xD;
                 2. Stop using intravenous diuretics;&#xD;
  &#xD;
                 3. Neither intravenous inotropic drugs or vasodilators were used (including&#xD;
                    nitrates).&#xD;
  &#xD;
            5. Subject is iron deficient defined as serum ferritin &lt;100 ng/mL or 100 ng/mL ≤ serum&#xD;
               ferritin ≤299 ng/mL if TSAT &lt;20%.&#xD;
  &#xD;
            6. Able and willing to provide informed consent and accomplish 6 minutes-walking test.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Hematological criteria: ferritin &gt;400 ug/L; hemoglobin &lt;9.0, hemoglobin &gt;13.5 g/dL in&#xD;
               women or &gt;14.5 g/dL in men.&#xD;
  &#xD;
            2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR)&#xD;
               &lt;15ml/min/1.73m2&#xD;
  &#xD;
            3. Body weight &lt;35kg at randomization.&#xD;
  &#xD;
            4. Heart failure was secondary to valvular diseases or congenital heart diseases.&#xD;
  &#xD;
            5. History of acquired iron overload or hemochromatosis (or first-degree relative of&#xD;
               hemochromatosis)&#xD;
  &#xD;
            6. Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or&#xD;
               any of its excipients (water for injections, sodium hydroxide (for pH adjustment),&#xD;
               hydrochloric acid (for pH adjustment)).&#xD;
  &#xD;
            7. Non-iron deficiency anaemia.&#xD;
  &#xD;
            8. Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in&#xD;
               previous 4 weeks prior to randomization.&#xD;
  &#xD;
            9. Active infection (defined as currently treated with oral or intravenous antibiotics),&#xD;
               bleeding (gastrointestinal haemorrhagia, menorrhagia, history of peptic ulcer with no&#xD;
               evidence of healing or inflammatory bowel disease) and history of malignant tumor.&#xD;
  &#xD;
           10. Any of the following diseases that hinders exercise testing: severe musculoskeletal&#xD;
               disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular&#xD;
               disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate&gt; 100 beats /&#xD;
               min at rest).&#xD;
  &#xD;
           11. Known positive HBsAg and/or HCV RNA; known HIV positivity; chronic liver disease&#xD;
               (including active hepatitis), hepatic sclerosis, ALT or AST &gt; 3x upper limit of&#xD;
               normal.&#xD;
  &#xD;
           12. Within 3 months of any of the following: acute myocardial infarction (AMI) or acute&#xD;
               coronary syndrome (ACS), transient ischemic attack (TIA) or stroke, uncontrolled&#xD;
               hypertension.&#xD;
  &#xD;
           13. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention,&#xD;
               or major surgery) in the past 3 months; or planning cardiac surgery or&#xD;
               revascularization.&#xD;
  &#xD;
           14. Baseline 6 minutes-walking distance&gt;500m.&#xD;
  &#xD;
           15. Treated with long-term oral high-dose or steroid-immunosuppression therapy.&#xD;
  &#xD;
           16. Investigator considers a possible alternative diagnosis to explain the patient's HF&#xD;
               symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive&#xD;
               pulmonary disease (COPD).&#xD;
  &#xD;
           17. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast&#xD;
               feeding.&#xD;
  &#xD;
           18. Untreated hypothyroidism.&#xD;
  &#xD;
           19. Currently enrolled in any other investigational device or drug study &lt;30 days prior to&#xD;
               screening, or received other investigational agent(s).&#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_contact>
      <last_name>Ying Zhou, Dr</last_name>
      <phone>+86-13699164283</phone>
      <email>929352903@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Peizhao Li, Dr</last_name>
      <phone>+86-18443151740</phone>
      <email>lipz7014@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>China-Japan Friendship Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ying Zhou, MD</last_name>
        <phone>+86-13699164283</phone>
        <email>929352903@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
      <investigator_full_name>Jingyi Ren</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Exercise capacity</keyword>
    <keyword>Quality of life</keyword>
    <keyword>Acute Heart Failure</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>
    <!-- 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/NCT05971732
  org study id: Monofer-HFrEF
  nct id: NCT05971732
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study will address whether the additional use of Ferric Derisomaltose on top of standard
        care will improve exercise capacity and quality of life in patients with acute heart failure
        and iron deficiency. One group of participants will receive treatment with Ferric
        Derisomaltose and the other group will receive normal saline 0.9% as placebo.
  Acute heart failure (AHF) is a very common medical problem. Despite improvements in
        treatment, many patients suffer limiting exercise capacity and quality of life. Previous
        comorbidities may account for it. Approximately 80% of patients hospitalized with AHF
        suffered from a combination of iron deficiency. A decline in exercise capacity may occur
        under this condition. Some research studies have suggested that giving CHF patients
        intravenous iron improves symptoms in the short term. It is unknown, however, whether
        correcting iron deficiency is beneficial to patients with AHF to improve excise capacity and
        whether it improves quality of life and accelerate recovery from acute duration. This study
        will help us answer these key questions.
  
        This is an investigator-initiated, randomised, parallel group, double-blind,
        placebo-controlled trial, evaluating the excise capacity improvement of using ferric
        derisomaltose versus placebo in hospitalized patients with acute heart failure with reduced
        ejection fraction before discharge.
  
        Participants will be assessed daily using 6-minute walking test after IV iron injection until
        discharge from hospital, especially focus on the change from baseline to the 3rd day. Some
        questionnaires are also conducted to evaluate the self-reported status. Participants will be
        followed up at 2 weeks and 4 weeks.
  
        The primary and secondary endpoints will be examined in subgroups predefined by baseline
        variables reflecting demography, Hb level, etiology of HF, left ventricular ejection
        fraction, natriuretic peptide, index of iron metabolism, eGFR and others.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Change in 6-minute walking distance
  time frame: Up to 3 days
  description: The difference of 6-minute walking distance in meters from baseline to day3 after IV iron injection.
  measure: Change From Baseline in 6-minute walking distance
  time frame: At 2 weeks, 4weeks after IV iron injection
  description: The difference of 6-minute walking distance in meters from baseline at 2 weeks, 4weeks after IV iron injection.
  measure: Change From Baseline in the KCCQ Clinical Summary Score
  time frame: At 2 weeks, 4weeks after IV iron injection
  description: KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
  measure: Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration.
  The descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state).
  measure: Change From Baseline in NYHA Functional Class
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: NYHA = New York Heart Association
  NYHA functional class was assessed as Class I, II, III, IV:
  Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
  Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
  Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
  Class IV - Severe limitations. Experiences symptoms even while at rest.
  Lower response categories are better for score NYHA.
  measure: Change From Baseline in PGA quality of life questionnaire
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: PGA:Patient Global Assessment
  PGA questionnaire consists of a health descriptive system for participants to self-reported and rate their medical condition after participate this study.
  The descriptive system includes 7 choices：has much improved, has (moderately) improved, has a little improved, is unchanged, is a little worse, is (moderately) worse, is much worse, which are coded from 1 (best state) to 7 (worst state).
  measure: Change From Baseline in Concentration of hemoglobin (Hb)
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: Hemoglobin (Hb) is a commonly used clinical test for assessing anaemia, with units of g/L.
  measure: Change From Baseline in proportion of reticulocyte (Ret%)
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: The reticulocyte ratio is often used to reflect the hematopoiesis of the bone marrow erythrocyte with units of percentage(%).
  measure: Change From Baseline in Concentration of ferritin
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: To assess the effect of ferric derisomaltose vs. placebo on change in ferritin from baseline to 3 days, 2weeks and 4weeks
  measure: Change From Baseline in concentration of transferrin saturation
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: To assess the effect of ferric derisomaltose vs. placebo on change in transferrin saturation from baseline to 3 days, 2weeks and 4weeks
  measure: Change From Baseline in Concentration of serum transferrin receptors (sTfR)
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: To assess the effect of ferric derisomaltose vs. placebo on change in serum transferrin receptors (sTfR) from baseline to 3 days, 2weeks and 4weeks
  measure: Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: To assess the effect of ferric derisomaltose vs. placebo on change in NT-proBNP from baseline to 3 days, 2weeks and 4weeks
  measure: Change From Baseline in Left Ventricular Systolic Function
  time frame: At 2weeks, 4weeks after IV iron injection
  description: Left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography.
  measure: Change From Baseline in Left Ventricular End-Diastolic Diameter
  time frame: At 2weeks, 4weeks after IV iron injection
  description: Left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.
  measure: Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR)
  time frame: At 3 days, 2weeks, 4weeks after IV iron injection
  description: Urine Albumin-to-Creatinine Ratio (UACR) is regard as a safety endpoint to reflect early injury of kidney.
  measure: A rise of high-sensitivity C-reaction protein (hs-CRP) levels from baseline
  time frame: Up to 4weeks
  description: Safety endpoint is defined as a rise of high-sensitivity C-reaction protein (hs-CRP) from baseline.
  measure: Adverse Event after IV iron injection
  time frame: Up to 4weeks
  description: Adverse Event Include Fishbane symptoms (flushing/chest pain/back pain/chest tightness, sometimes with dyspnea), isolated signs and symptoms (urticaria/pruritus/rash/mild hypotension, hypertension/tachycardia/nausea/headache), signs and symptoms of allergic reactions (persistent hypotension; airway angioedema/generalised urticaria, non-airway angioedema/wheezing, bronchospasm, vomiting, abdominal pain, etc.)
  arm group label: Ferric derisomaltose
  arm group type: Experimental
  description: Iron to be administered as ferric derisomaltose.
  The treatment dose (mL) to be administered will be determined by the patient's body weight and hemoglobin (Hb) value.
  Where Hb ≥10 g/dL, dosage according to body weight is as follows:
  Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg.
  Where Hb <10 g/dL, dosage according to body weight is as follows:
  Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg.
  Infused over a minimum of 15mins for doses up to and including 1000mg, and a minimum of 30 mins for doses >1000mg
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants in this arm will receive normal saline 0.9% in analogy to treatment arm.
  intervention type: Drug
  intervention name: Ferric derisomaltose
  description: After baseline assessments patients will be randomised in a 1:1 ratio to receive ferric derisomaltose IV or placebo (normal saline). In the Treatment group, Ferric derisomaltose will be administered according to the dosing schedule.
  arm group label: Ferric derisomaltose
  other name: Monofer
  other name: Iron (III) isomaltoside 1000
  intervention type: Drug
  intervention name: Placebo
  description: In the placebo group, patients will receive the equivalent number of normal saline injections.
  arm group label: Placebo
  other name: Normal saline
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ying Zhou, Dr
  phone: +86-13699164283
  email: 929352903@qq.com
  last name: Peizhao Li, Dr
  phone: +86-18443151740
  email: lipz7014@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: China-Japan Friendship Hospital
  investigator full name: Jingyi Ren
  investigator title: Professor
  mesh term: Heart Failure
  mesh term: Anemia, Iron-Deficiency
  mesh term: Iron Deficiencies