<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/NCT03289637</url>
  </required_header>
  <id_info>
    <org_study_id>D-88538-Sw</org_study_id>
    <nct_id>NCT03289637</nct_id>
  </id_info>
  <brief_title>Supplementation With Vitamin D to Patients With Heart Failure (D-Heart).</brief_title>
  <acronym>D-Heart</acronym>
  <official_title>Supplementation With Vitamin D to Patients With Heart Failure. Effects on Symptoms, Quality-of-life and Disease Processes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 200 patients with documented systolic heart failure give supplementation with vitamin D in&#xD;
      those with a 25-OH- vitamin D &lt; 50nmol/L - or placebo.&#xD;
&#xD;
      In those with a vitamin D level &lt;25nmol/L a substitution of 2400IU will be given, and in&#xD;
      those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given.&#xD;
&#xD;
      Intervention time 12 months. Biomarkers of heart function, quality of life, and&#xD;
      hospitalisation will be analysed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a population with a systolic heart failure with an EF&lt;40%, the levels of vitamin D will be&#xD;
      analysed. In those with a 25-OH-vitamin D level &lt;50nmol/L the patients that accept&#xD;
      participation, will be randomised into active supplementation as described below, or placebo.&#xD;
&#xD;
        -  In those with a 25-OH-vitamin D level &lt;25nmol/L there will be a supplementation of&#xD;
           2400IU daily&#xD;
&#xD;
        -  In those with a vitamin D level 25-50nmol/L there will be a supplementation of 1600IU&#xD;
           daily,&#xD;
&#xD;
        -  or placebo. Thus based on the basal level of vitamin D the screened patients will either&#xD;
           be excluded due to high level of vitamin D, or given one ot the two options of vitamin D&#xD;
           dosage based on the basal patient level - or placebo.&#xD;
&#xD;
      The intervention time will be 12 months. In the project 200 heart failure patients will be&#xD;
      included. Blood samples including heart failure biomarkers, and biomarkers for inflammation&#xD;
      and oxidative stress will be drawn at 3,6, 9 and 12 months.&#xD;
&#xD;
      Health related quality of life will be evaluated by use of Euro-QoL-5D Minnesota Living with&#xD;
      Heart Failure.Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20&#xD;
      questionnaire, as also hospitalisation during the project time.&#xD;
&#xD;
      Cardiac function according to echocardiography will be analysed at start, and study end.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">February 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Double blind, parallel, placebo controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Neither the participant, nor the care provider will be informed if active supplementation or placebo will be given, nor will blood sample results be open for care provider</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in the composite endpoint for heart failure</measure>
    <time_frame>Follow-up 12 months after stop of intervention</time_frame>
    <description>Reduction in biomarkers for heart failure(Nt-proBNP, Copeptin, MR-proADM and Chromogranin A) and in hospitalisation that comprised the composite endpoint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence on quality of life in patients with heart failure by the intervention</measure>
    <time_frame>Follow-up 12 months after stop of intervention</time_frame>
    <description>Effect on health related quality of life as measured by the Euro-QoL-5D Minnesota Living with Heart Failure. Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaires</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Influence on quality of life in patients with heart failure by the intervention</measure>
    <time_frame>Follow-up 12 months after termination of the intervention</time_frame>
    <description>Effect on health related quality of life as measured by Minnesota Living with Heart Failure</description>
  </other_outcome>
  <other_outcome>
    <measure>Influence on symptoms of depression in patients with heart failure by the intervention</measure>
    <time_frame>Follow-up 12 months after termination of intervention</time_frame>
    <description>Patient Health Questionnaire-9 (PHQ-9)</description>
  </other_outcome>
  <other_outcome>
    <measure>Influence on perceived fatigue in patients with heart failure by the intervention</measure>
    <time_frame>Follow-up 12 months after termination of the intervention</time_frame>
    <description>Effect on as measured using the Multidimensional Fatigue Inventory 20</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Heart Failure With Reduced Ejection Fraction</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Active intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the group randomised to active treatment and with a screening level of 25-OH-vitamin D 25-50nmol/L an intervention with 1600IE daily of vitamin D will be given.&#xD;
In those randomised to active treatment and with a screening level of 25-OH-vitamin D of &lt;25nmol/L, an intervention of 2400IE of vitamin D will be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the group randomised to placebo and with a screening level of 25-OH-vitamin D &lt;50 mol/L, the participants will be given placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level&lt;50nmol/L at screening</description>
    <arm_group_label>Active intervention</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with documented and stable systolic heart failure and connected to an&#xD;
             outpatient clinic at the Dept of Cardiology in Linköping, or Jönköping, Sweden, and&#xD;
             with a 25-OH-vitamin D &lt;50nmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with unstable heart failure&#xD;
&#xD;
          -  Patients with significant valvular disease, or ischemic heart disease planned for&#xD;
             operation&#xD;
&#xD;
          -  Patients with significant renal or /and liver impairment.&#xD;
&#xD;
          -  Patients that do not understand that study information, or that are not willing to&#xD;
             participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urban Alehagen, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Linköping</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Urban Alehagen, Prof</last_name>
    <phone>+46-10-1030000</phone>
    <email>urban.alehagen@liu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peter Johansson, Ass Prof</last_name>
    <phone>+46-10-1030000</phone>
    <email>peter.b.johansson@liu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dept of Cardiology, University Hospital of Linköping</name>
      <address>
        <city>Linköping</city>
        <zip>58191</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Wodlin, MD</last_name>
      <email>peter.wodlin@regionostergotland.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Urban Alehagen</investigator_full_name>
    <investigator_title>Professor, MD.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_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/NCT03289637
org study id: D-88538-Sw
nct id: NCT03289637
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In 200 patients with documented systolic heart failure give supplementation with vitamin D in
      those with a 25-OH- vitamin D < 50nmol/L - or placebo.

      In those with a vitamin D level <25nmol/L a substitution of 2400IU will be given, and in
      those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given.

      Intervention time 12 months. Biomarkers of heart function, quality of life, and
      hospitalisation will be analysed.
In a population with a systolic heart failure with an EF<40%, the levels of vitamin D will be
      analysed. In those with a 25-OH-vitamin D level <50nmol/L the patients that accept
      participation, will be randomised into active supplementation as described below, or placebo.

        -  In those with a 25-OH-vitamin D level <25nmol/L there will be a supplementation of
           2400IU daily

        -  In those with a vitamin D level 25-50nmol/L there will be a supplementation of 1600IU
           daily,

        -  or placebo. Thus based on the basal level of vitamin D the screened patients will either
           be excluded due to high level of vitamin D, or given one ot the two options of vitamin D
           dosage based on the basal patient level - or placebo.

      The intervention time will be 12 months. In the project 200 heart failure patients will be
      included. Blood samples including heart failure biomarkers, and biomarkers for inflammation
      and oxidative stress will be drawn at 3,6, 9 and 12 months.

      Health related quality of life will be evaluated by use of Euro-QoL-5D Minnesota Living with
      Heart Failure.Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20
      questionnaire, as also hospitalisation during the project time.

      Cardiac function according to echocardiography will be analysed at start, and study end.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blind, parallel, placebo controlled study
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: Neither the participant, nor the care provider will be informed if active supplementation or placebo will be given, nor will blood sample results be open for care provider
measure: Reduction in the composite endpoint for heart failure
time frame: Follow-up 12 months after stop of intervention
description: Reduction in biomarkers for heart failure(Nt-proBNP, Copeptin, MR-proADM and Chromogranin A) and in hospitalisation that comprised the composite endpoint
measure: Influence on quality of life in patients with heart failure by the intervention
time frame: Follow-up 12 months after stop of intervention
description: Effect on health related quality of life as measured by the Euro-QoL-5D Minnesota Living with Heart Failure. Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaires
measure: Influence on quality of life in patients with heart failure by the intervention
time frame: Follow-up 12 months after termination of the intervention
description: Effect on health related quality of life as measured by Minnesota Living with Heart Failure
measure: Influence on symptoms of depression in patients with heart failure by the intervention
time frame: Follow-up 12 months after termination of intervention
description: Patient Health Questionnaire-9 (PHQ-9)
measure: Influence on perceived fatigue in patients with heart failure by the intervention
time frame: Follow-up 12 months after termination of the intervention
description: Effect on as measured using the Multidimensional Fatigue Inventory 20
arm group label: Active intervention
arm group type: Experimental
description: In the group randomised to active treatment and with a screening level of 25-OH-vitamin D 25-50nmol/L an intervention with 1600IE daily of vitamin D will be given.
In those randomised to active treatment and with a screening level of 25-OH-vitamin D of <25nmol/L, an intervention of 2400IE of vitamin D will be given.
arm group label: Placebo
arm group type: Placebo Comparator
description: In the group randomised to placebo and with a screening level of 25-OH-vitamin D <50 mol/L, the participants will be given placebo.
intervention type: Dietary Supplement
intervention name: Vitamin D
description: Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level<50nmol/L at screening
arm group label: Active intervention
arm group label: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Urban Alehagen, Prof
role: Principal Investigator
affiliation: University of Linköping
last name: Urban Alehagen, Prof
phone: +46-10-1030000
email: urban.alehagen@liu.se
last name: Peter Johansson, Ass Prof
phone: +46-10-1030000
email: peter.b.johansson@liu.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Urban Alehagen
investigator title: Professor, MD.
mesh term: Heart Failure
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
sharing ipd: No