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/NCT06030843</url>
    </required_header>
    <id_info>
      <org_study_id>IRB 674/66</org_study_id>
      <nct_id>NCT06030843</nct_id>
    </id_info>
    <brief_title>The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1</brief_title>
    <acronym>TREAT-CRS</acronym>
    <official_title>The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chulalongkorn University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chulalongkorn University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by&#xD;
        MAKE30.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2024</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>MAKE30</measure>
      <time_frame>30 days</time_frame>
      <description>The composite outcome of death, new dialysis, and sustained loss of kidney function (which was defined as a 25% or greater decline in eGFR from baseline) assess at 30 days following randomization</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>In-hospital mortality rate</measure>
      <time_frame>During admission</time_frame>
      <description>In-hospital mortality rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30-days mortality rate</measure>
      <time_frame>30 days</time_frame>
      <description>30-days mortality rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Initiation of Renal Replacement therapy</measure>
      <time_frame>30 days</time_frame>
      <description>Initiation of Renal Replacement therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR</measure>
      <time_frame>30 days</time_frame>
      <description>Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrent heart failure</measure>
      <time_frame>30 days</time_frame>
      <description>Recurrent heart failure required hospital administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vasoactive drug</measure>
      <time_frame>30 days</time_frame>
      <description>Vasoactive drug use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mechanical ventilation</measure>
      <time_frame>30 days</time_frame>
      <description>Mechanical ventilation use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventricular tachycardia or ventricular fibrillation</measure>
      <time_frame>30 days</time_frame>
      <description>Ventricular tachycardia or ventricular fibrillation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resuscitation following a cardiac arrest</measure>
      <time_frame>30 days</time_frame>
      <description>Resuscitation following a cardiac arrest</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction of prespecified renal biomarkers</measure>
      <time_frame>30 days</time_frame>
      <description>Reduction of prespecified renal biomarkers</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Empagliflozin in Cardiorenal Syndrome Type 1</condition>
    <arm_group>
      <arm_group_label>Empagliflozin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Empagliflozin 10 mg po OD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Matching placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Empagliflozin 10 MG</intervention_name>
      <description>Empagliflozin 10 MG</description>
      <arm_group_label>Empagliflozin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching placebo containing Lactose content (0.26 gram)</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Age 18 years or more&#xD;
  &#xD;
            -  Hospitalized for the primary diagnosis of acute denovo or decompensated chronic heart&#xD;
               regardless of ejection fraction&#xD;
  &#xD;
            -  AKI KDIGO any stage or urine NGAL ≥ 150 ng/mL&#xD;
  &#xD;
            -  Must be able to be enrolled into the trial ≤ 12 hours of diagnosis of AKI or elevated&#xD;
               urine NGAL&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Denied to participate in the study&#xD;
  &#xD;
            -  Cardiogenic shock or unstable hemodynamic (systolic blood pressure of at least 100&#xD;
               mmHg or required inotropic support within last 24 hours)&#xD;
  &#xD;
            -  Cardiac mechanical support (i.e. extracorporeal membrane oxygenation and intra-aortic&#xD;
               balloon pump)&#xD;
  &#xD;
            -  Acute coronary syndrome&#xD;
  &#xD;
            -  Diagnosed with cause of AKI other than cardiorenal syndrome (eg. sepsis, nephrotoxic,&#xD;
               dehydration)&#xD;
  &#xD;
            -  Anuria or requiring dialysis or expected to required dialysis within 24 hr&#xD;
  &#xD;
            -  Baseline eGFR ≤ 20 ml/min/1.73m2 with or without dialysis initiated&#xD;
  &#xD;
            -  Heart or kidney transplanted&#xD;
  &#xD;
            -  Previously received any SGLT2i in the last 3 months before admission&#xD;
  &#xD;
            -  Allergic to any SGLT2i&#xD;
  &#xD;
            -  Type 1 diabetes mellitus&#xD;
  &#xD;
            -  History of ketoacidosis, including diabetic ketoacidosis&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Comorbid conditions with an expected survival of less than 1 months such as end-stage&#xD;
               liver or heart disease, or uncurable malignancy&#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_official>
      <last_name>Nattachai Srisawat</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chulalongkorn University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sasipha Tachaboon</last_name>
      <phone>022564000</phone>
      <phone_ext>3679</phone_ext>
      <email>sasipha_tac@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Medicine, Chulalongkorn University</name>
        <address>
          <city>Bangkok</city>
          <state>Pathumwan</state>
          <zip>10330</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Thailand</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
      <investigator_full_name>Nattachai Srisawat ,M.D.</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Empagliflozin</keyword>
    <keyword>SGLT2i</keyword>
    <keyword>Cardiorenal syndrome</keyword>
    <keyword>ADHF</keyword>
    <keyword>AKI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardio-Renal Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Empagliflozin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06030843
  org study id: IRB 674/66
  nct id: NCT06030843
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by
        MAKE30.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: MAKE30
  time frame: 30 days
  description: The composite outcome of death, new dialysis, and sustained loss of kidney function (which was defined as a 25% or greater decline in eGFR from baseline) assess at 30 days following randomization
  measure: In-hospital mortality rate
  time frame: During admission
  description: In-hospital mortality rate
  measure: 30-days mortality rate
  time frame: 30 days
  description: 30-days mortality rate
  measure: Initiation of Renal Replacement therapy
  time frame: 30 days
  description: Initiation of Renal Replacement therapy
  measure: Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
  time frame: 30 days
  description: Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
  measure: Recurrent heart failure
  time frame: 30 days
  description: Recurrent heart failure required hospital administration
  measure: Vasoactive drug
  time frame: 30 days
  description: Vasoactive drug use
  measure: Mechanical ventilation
  time frame: 30 days
  description: Mechanical ventilation use
  measure: Ventricular tachycardia or ventricular fibrillation
  time frame: 30 days
  description: Ventricular tachycardia or ventricular fibrillation
  measure: Resuscitation following a cardiac arrest
  time frame: 30 days
  description: Resuscitation following a cardiac arrest
  measure: Reduction of prespecified renal biomarkers
  time frame: 30 days
  description: Reduction of prespecified renal biomarkers
  arm group label: Empagliflozin
  arm group type: Experimental
  description: Empagliflozin 10 mg po OD
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Matching placebo
  intervention type: Drug
  intervention name: Empagliflozin 10 MG
  description: Empagliflozin 10 MG
  arm group label: Empagliflozin
  intervention type: Drug
  intervention name: Placebo
  description: Matching placebo containing Lactose content (0.26 gram)
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nattachai Srisawat
  role: Principal Investigator
  affiliation: Chulalongkorn University
  last name: Sasipha Tachaboon
  phone: 022564000
  phone ext: 3679
  email: sasipha_tac@hotmail.com
  facility: 
  country: Thailand
  responsible party type: Principal Investigator
  investigator affiliation: Chulalongkorn University
  investigator full name: Nattachai Srisawat ,M.D.
  investigator title: Professor
  mesh term: Cardio-Renal Syndrome
  mesh term: Syndrome
  mesh term: Empagliflozin
  sharing ipd: Undecided