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/NCT05967156</url>
    </required_header>
    <id_info>
      <org_study_id>SBMU--</org_study_id>
      <nct_id>NCT05967156</nct_id>
    </id_info>
    <brief_title>Empagliflozin in Heart Failure Dialysis Patients</brief_title>
    <official_title>Safety and Efficacy of Empagliflozin on Heart Failure Dialysis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shahid Beheshti University of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shahid Beheshti University of Medical Sciences</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Empagliflozin is not still approved for glomerular filtration rate &lt; 20 cc/min/1.73m2.&#xD;
        Considering the cardiac and renal benefits of this drug, the evaluation of the safety and&#xD;
        efficacy of Empagliflozin for heart failure dialysis patients seems to be mandatory.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Heart failure dialysis patients with residual renal function will be followed up on&#xD;
        Empagliflozin based on echocardiographic parameters, pro-brain natriuretic peptide levels,&#xD;
        diuresis volume, and serum acidity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Brain Natriuretic Peptide</measure>
      <time_frame>one month after administration</time_frame>
      <description>serum level</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Heart Failure</condition>
    <condition>Hemodialysis</condition>
    <arm_group>
      <arm_group_label>Empagliflozin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Heart failure dialysis patients will be treated with Empagliflozin</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Empagliflozin10Mg Tab</intervention_name>
      <description>10 mg daily</description>
      <arm_group_label>Empagliflozin</arm_group_label>
      <other_name>Abide</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Heart failure on dialysis with residual renal function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dialysis patients with no residual urine&#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>Dalili</last_name>
      <role>Principal Investigator</role>
      <affiliation>SMBU</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dalili</last_name>
      <phone>9122404331</phone>
      <phone_ext>0098</phone_ext>
      <email>dr.nooshindalili@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nooshin Dalili</name>
        <address>
          <city>Tehran</city>
          <zip>1666663421</zip>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nooshin Dalili, Dr</last_name>
        <phone>00989122404331</phone>
        <email>nooshindalili4@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
      <investigator_full_name>nooshin dalili</investigator_full_name>
      <investigator_title>Assistant Professor</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Empagliflozin</mesh_term>
    </intervention_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/NCT05967156
  org study id: SBMU--
  nct id: NCT05967156
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Empagliflozin is not still approved for glomerular filtration rate < 20 cc/min/1.73m2.
        Considering the cardiac and renal benefits of this drug, the evaluation of the safety and
        efficacy of Empagliflozin for heart failure dialysis patients seems to be mandatory.
  Heart failure dialysis patients with residual renal function will be followed up on
        Empagliflozin based on echocardiographic parameters, pro-brain natriuretic peptide levels,
        diuresis volume, and serum acidity.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Brain Natriuretic Peptide
  time frame: one month after administration
  description: serum level
  arm group label: Empagliflozin
  arm group type: Experimental
  description: Heart failure dialysis patients will be treated with Empagliflozin
  intervention type: Drug
  intervention name: Empagliflozin10Mg Tab
  description: 10 mg daily
  arm group label: Empagliflozin
  other name: Abide
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Dalili
  role: Principal Investigator
  affiliation: SMBU
  last name: Dalili
  phone: 9122404331
  phone ext: 0098
  email: dr.nooshindalili@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Shahid Beheshti University of Medical Sciences
  investigator full name: nooshin dalili
  investigator title: Assistant Professor
  mesh term: Heart Failure
  mesh term: Empagliflozin