<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/NCT03772275</url>
  </required_header>
  <id_info>
    <org_study_id>Heart failure</org_study_id>
    <nct_id>NCT03772275</nct_id>
  </id_info>
  <brief_title>Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure</brief_title>
  <official_title>Clinical and Economical Study Evaluating the Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sherief Abd-Elsalam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical and Economic study of some new biomarkers in chronic heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aimed at evaluation of the clinical and economic value of some new biomarkers in&#xD;
      chronic heart failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">October 2027</completion_date>
  <primary_completion_date type="Anticipated">October 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with elevated markers (IL17)</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants with elevated markers (IL17)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>New york Heart Association Class II-IV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>New york Heart Association Class II-IV heart failure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>New york Heart Association Class I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>New york Heart Association Class I with no heart failure</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>New york Heart Association Class II-IV</intervention_name>
    <description>New york Heart Association Class II-IV &quot; study of markers&quot;</description>
    <arm_group_label>New york Heart Association Class II-IV</arm_group_label>
    <other_name>Severe heart failure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>New york Heart Association Class I</intervention_name>
    <description>New york Heart Association Class I</description>
    <arm_group_label>New york Heart Association Class I</arm_group_label>
    <other_name>No heart failure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NYHA-Class II-IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver or renal dysfunction. --DM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Osama M Ibrahim, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prof of Clinical Pharmacy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Medhat M Eshmawy, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Cardiology Department- Tanta University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nermin W Ishaq, Msc</last_name>
    <role>Study Chair</role>
    <affiliation>Clinical pharmacy Department- Tanta University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherief Abd-Elsalam, Ph D</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <state>Elgharbia</state>
        <zip>35111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nermin W Ishak, Msc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 8, 2018</last_update_submitted>
  <last_update_submitted_qc>December 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Ass. Prof. Tropical Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03772275
org study id: Heart failure
nct id: NCT03772275
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Clinical and Economic study of some new biomarkers in chronic heart failure.
The study aimed at evaluation of the clinical and economic value of some new biomarkers in
      chronic heart failure.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of participants with elevated markers (IL17)
time frame: 6 months
description: Number of participants with elevated markers (IL17)
arm group label: New york Heart Association Class II-IV
arm group type: Active Comparator
description: New york Heart Association Class II-IV heart failure
arm group label: New york Heart Association Class I
arm group type: Active Comparator
description: New york Heart Association Class I with no heart failure
intervention type: Diagnostic Test
intervention name: New york Heart Association Class II-IV
description: New york Heart Association Class II-IV " study of markers"
arm group label: New york Heart Association Class II-IV
other name: Severe heart failure
intervention type: Diagnostic Test
intervention name: New york Heart Association Class I
description: New york Heart Association Class I
arm group label: New york Heart Association Class I
other name: No heart failure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Osama M Ibrahim, Prof
role: Principal Investigator
affiliation: Prof of Clinical Pharmacy
last name: Medhat M Eshmawy, Prof
role: Study Director
affiliation: Cardiology Department- Tanta University
last name: Nermin W Ishaq, Msc
role: Study Chair
affiliation: Clinical pharmacy Department- Tanta University
last name: Sherief Abd-Elsalam, Ph D
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Ass. Prof. Tropical Medicine
mesh term: Heart Failure
sharing ipd: Undecided