<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/NCT04447911</url>
  </required_header>
  <id_info>
    <org_study_id>EMPOWER study</org_study_id>
    <nct_id>NCT04447911</nct_id>
  </id_info>
  <brief_title>Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia</brief_title>
  <acronym>EMPOWER</acronym>
  <official_title>Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial (the EMPOWER Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Luzerner Kantonsspital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Hyponatremia is the most common electrolyte derangement occurring in hospitalized patients.&#xD;
      It is usually classified as hypovolemic, euvolemic or hypervolemic. The most common aetiology&#xD;
      of euvolemic hyponatremia is the syndrome of inappropriate antidiuresis (SIAD). Hypervolemic&#xD;
      hyponatremia is common in patients with congestive heart failure (CHF) (10-27%) and liver&#xD;
      cirrhosis (up to approximately 50%). In SIAD, the regulation of arginine vasopressin (AVP)&#xD;
      secretion is impaired which leads to free water retention. In CHF and liver cirrhosis, the&#xD;
      effective arterial blood volume is decreased leading to non-osmotic baroreceptor mediated AVP&#xD;
      release and consecutive free water retention.&#xD;
&#xD;
      Current treatments of euvolemic and hypervolemic hyponatremia, including the most used&#xD;
      treatment fluid restriction, are of limited efficacy. Sodium-Glucose-Co-Transporter 2 (SGLT2)&#xD;
      inhibitors reduce glucose reabsorption in the proximal tubule, resulting in glucosuria and&#xD;
      consecutive osmotic diuresis. A placebo-controlled randomized trial of our group has shown&#xD;
      that a short-term, i.e. a 4-days administration of the SGLT2 inhibitor empagliflozin&#xD;
      (Jardiance)® in addition to fluid restriction was effective in increasing the serum sodium&#xD;
      concentration in 87 patients with SIAD-induced hyponatremia. The effect of empagliflozin&#xD;
      (Jardiance)® without additional fluid restriction is however not yet known. Large randomized&#xD;
      controlled trials have shown that SGLT2 inhibitors reduced hospitalization for heart failure&#xD;
      in patients with, and more recently without type 2 diabetes. No studies have investigated the&#xD;
      effect of SGLT2 inhibitors in hypervolemic hyponatremia.&#xD;
&#xD;
      To evaluate the effect of empagliflozin (Jardiance)® in eu- and hypervolemic hyponatremia, a&#xD;
      randomized placebo-controlled study is needed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2021</start_date>
  <completion_date type="Anticipated">February 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>
    <intervention_model_description>Multicentric prospective randomized double-blind placebo-controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in average daily area under curve (AUC) for serum sodium concentration</measure>
    <time_frame>4 days</time_frame>
    <description>Change in average daily AUC for serum sodium concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term serum sodium change (before/after treatment)</measure>
    <time_frame>30 days</time_frame>
    <description>Absolute change in serum sodium concentration from baseline to end of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact intervention on bodyweight</measure>
    <time_frame>30 days</time_frame>
    <description>change of bodyweight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact intervention on blood pressure</measure>
    <time_frame>30 days</time_frame>
    <description>change of blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Course of serum sodium level</measure>
    <time_frame>30 days</time_frame>
    <description>Course of serum sodium level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of plasma osmolality</measure>
    <time_frame>30 days</time_frame>
    <description>Change of plasma osmolality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of urinary osmolality</measure>
    <time_frame>30 days</time_frame>
    <description>Change of urinary osmolality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of plasma urea</measure>
    <time_frame>30 days</time_frame>
    <description>Change of plasma urea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of urinary urea</measure>
    <time_frame>30 days</time_frame>
    <description>Change of urinary urea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of plasma uric acid</measure>
    <time_frame>30 days</time_frame>
    <description>Change of plasma uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of urinary uric acid</measure>
    <time_frame>30 days</time_frame>
    <description>Change of urinary uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of plasma creatinin</measure>
    <time_frame>30 days</time_frame>
    <description>Change of plasma creatinin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of urinary creatinin</measure>
    <time_frame>30 days</time_frame>
    <description>Change of urinary creatinin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of plasma potassium</measure>
    <time_frame>30 days</time_frame>
    <description>Change of plasma potassium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of urinary potassium</measure>
    <time_frame>30 days</time_frame>
    <description>Change of urinary potassium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma copeptin</measure>
    <time_frame>30 days</time_frame>
    <description>Change in plasma copeptin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma aldosterone</measure>
    <time_frame>30 days</time_frame>
    <description>Change in plasma aldosterone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma renin</measure>
    <time_frame>30 days</time_frame>
    <description>Change in plasma renin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma MR-proANP</measure>
    <time_frame>30 days</time_frame>
    <description>Change in plasma MR-proANP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma NT-proBNP</measure>
    <time_frame>30 days</time_frame>
    <description>Change in plasma NT-proBNP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma CTX</measure>
    <time_frame>30 days</time_frame>
    <description>Change in plasma CTX</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma P1NP</measure>
    <time_frame>30 days</time_frame>
    <description>Change in plasma P1NP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of thirst</measure>
    <time_frame>30 days</time_frame>
    <description>Occurence of thirst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of headache</measure>
    <time_frame>30 days</time_frame>
    <description>Occurence of headache</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of vertigo</measure>
    <time_frame>30 days</time_frame>
    <description>Occurence of vertigo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of nausea</measure>
    <time_frame>30 days</time_frame>
    <description>Occurence of nausea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in general well-being</measure>
    <time_frame>30 days</time_frame>
    <description>Change in general well-being according to visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>30 days</time_frame>
    <description>change in quality of life according to EQ-5D-5L questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive impairment</measure>
    <time_frame>30 days</time_frame>
    <description>Change in cognitive impairment measured with the MoCa test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in visual attention</measure>
    <time_frame>30 days</time_frame>
    <description>Change in visual attention measured with the trail making test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in neuromuscular impairment</measure>
    <time_frame>30 days</time_frame>
    <description>Change in neuromuscular impairment measured with the timed up and go test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in grip strength</measure>
    <time_frame>30 days</time_frame>
    <description>Change in grip strength measured with a hand dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of falls</measure>
    <time_frame>30 days</time_frame>
    <description>Occurence of falls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of fractures</measure>
    <time_frame>30 days</time_frame>
    <description>Occurence of fractures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>Length of hospital stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">172</enrollment>
  <condition>Hyponatremia</condition>
  <condition>SIADH</condition>
  <condition>Liver Failure</condition>
  <condition>Kidney Failure</condition>
  <arm_group>
    <arm_group_label>Empagliflozin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empagliflozin (Jardiance)® 25mg per os once daily for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (Lactose tablet) per os once daily for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin 25 MG</intervention_name>
    <description>Empagliflozin 25mg per os once daily for 30 days</description>
    <arm_group_label>Empagliflozin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo per os once daily for 30 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - chronic eu- OR hypervolemic non hyperosmolar (&lt;300 mOsm/kg) hyponatremia (heparin plasma&#xD;
        sodium &lt;135 mmol/L on day of inclusion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known hypersensitivity or allergy to class of drugs or the investigational product,&#xD;
&#xD;
          -  severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need&#xD;
             of intensive/intermediate care treatment at time of inclusion&#xD;
&#xD;
          -  clinical hypovolemia&#xD;
&#xD;
          -  Severe reduction of eGFR &lt;20 mL/min/1,73 m2 (KDIGO G4 and G5) or end stage renal&#xD;
             disease&#xD;
&#xD;
          -  Chronic liver insufficiency with Child Pugh Score ≥10 or decompensated liver cirrhosis&#xD;
             (jaundice, hepatorenal syndrome, encephalopathy, bleeding, …)&#xD;
&#xD;
          -  Hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase&#xD;
             (ALT) &gt;3x the upper limit of normal (ULN); or total bilirubin &gt;2x ULN at time of&#xD;
             enrolment&#xD;
&#xD;
          -  uncontrolled hypothyroidism&#xD;
&#xD;
          -  uncontrolled adrenal insufficiency&#xD;
&#xD;
          -  systolic blood pressure &lt;90mmHg&#xD;
&#xD;
          -  contraindication for lowering blood pressure&#xD;
&#xD;
          -  diabetes mellitus type 1 or pancreatic diabetes mellitus&#xD;
&#xD;
          -  treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on&#xD;
             inclusion day&#xD;
&#xD;
          -  severe immunosuppression (leucocytes &lt;2 G/l)&#xD;
&#xD;
          -  peripheral arterial disease stage III-IV of the Fontaine Classification&#xD;
&#xD;
          -  fasting or other reasons preventing medication intake&#xD;
&#xD;
          -  previous enrolment into the current study&#xD;
&#xD;
          -  participation in another intervention study&#xD;
&#xD;
          -  pregnancy, breastfeeding, intention to become pregnant during the course of the study&#xD;
             or lack of safe contraception.&#xD;
&#xD;
          -  end of life care&#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>Julie Refardt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mirjam Christ-Crain, Prof</last_name>
    <phone>+41 61 328 70 80</phone>
    <email>Mirjam.Christ-Crain@usb.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois (CHUV)</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Zanchi, MD</last_name>
      <phone>+41 21 314 11 11</phone>
      <email>anne.zanchi@chuv.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie Monnerat, MD</last_name>
      <phone>0041 61 328 76 08</phone>
      <email>sophie.monnerat@usb.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Luzern</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Fischli, MD</last_name>
      <phone>+ 41 41 205 51 03</phone>
      <email>stefan.fischli@luks.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Hyponatremia</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>Yes</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/NCT04447911
org study id: EMPOWER study
nct id: NCT04447911
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hyponatremia is the most common electrolyte derangement occurring in hospitalized patients.
      It is usually classified as hypovolemic, euvolemic or hypervolemic. The most common aetiology
      of euvolemic hyponatremia is the syndrome of inappropriate antidiuresis (SIAD). Hypervolemic
      hyponatremia is common in patients with congestive heart failure (CHF) (10-27%) and liver
      cirrhosis (up to approximately 50%). In SIAD, the regulation of arginine vasopressin (AVP)
      secretion is impaired which leads to free water retention. In CHF and liver cirrhosis, the
      effective arterial blood volume is decreased leading to non-osmotic baroreceptor mediated AVP
      release and consecutive free water retention.

      Current treatments of euvolemic and hypervolemic hyponatremia, including the most used
      treatment fluid restriction, are of limited efficacy. Sodium-Glucose-Co-Transporter 2 (SGLT2)
      inhibitors reduce glucose reabsorption in the proximal tubule, resulting in glucosuria and
      consecutive osmotic diuresis. A placebo-controlled randomized trial of our group has shown
      that a short-term, i.e. a 4-days administration of the SGLT2 inhibitor empagliflozin
      (Jardiance)® in addition to fluid restriction was effective in increasing the serum sodium
      concentration in 87 patients with SIAD-induced hyponatremia. The effect of empagliflozin
      (Jardiance)® without additional fluid restriction is however not yet known. Large randomized
      controlled trials have shown that SGLT2 inhibitors reduced hospitalization for heart failure
      in patients with, and more recently without type 2 diabetes. No studies have investigated the
      effect of SGLT2 inhibitors in hypervolemic hyponatremia.

      To evaluate the effect of empagliflozin (Jardiance)® in eu- and hypervolemic hyponatremia, a
      randomized placebo-controlled study is needed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicentric prospective randomized double-blind placebo-controlled study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in average daily area under curve (AUC) for serum sodium concentration
time frame: 4 days
description: Change in average daily AUC for serum sodium concentration
measure: Long-term serum sodium change (before/after treatment)
time frame: 30 days
description: Absolute change in serum sodium concentration from baseline to end of treatment
measure: Impact intervention on bodyweight
time frame: 30 days
description: change of bodyweight
measure: Impact intervention on blood pressure
time frame: 30 days
description: change of blood pressure
measure: Course of serum sodium level
time frame: 30 days
description: Course of serum sodium level
measure: Change of plasma osmolality
time frame: 30 days
description: Change of plasma osmolality
measure: Change of urinary osmolality
time frame: 30 days
description: Change of urinary osmolality
measure: Change of plasma urea
time frame: 30 days
description: Change of plasma urea
measure: Change of urinary urea
time frame: 30 days
description: Change of urinary urea
measure: Change of plasma uric acid
time frame: 30 days
description: Change of plasma uric acid
measure: Change of urinary uric acid
time frame: 30 days
description: Change of urinary uric acid
measure: Change of plasma creatinin
time frame: 30 days
description: Change of plasma creatinin
measure: Change of urinary creatinin
time frame: 30 days
description: Change of urinary creatinin
measure: Change of plasma potassium
time frame: 30 days
description: Change of plasma potassium
measure: Change of urinary potassium
time frame: 30 days
description: Change of urinary potassium
measure: Change in plasma copeptin
time frame: 30 days
description: Change in plasma copeptin
measure: Change in plasma aldosterone
time frame: 30 days
description: Change in plasma aldosterone
measure: Change in plasma renin
time frame: 30 days
description: Change in plasma renin
measure: Change in plasma MR-proANP
time frame: 30 days
description: Change in plasma MR-proANP
measure: Change in plasma NT-proBNP
time frame: 30 days
description: Change in plasma NT-proBNP
measure: Change in plasma CTX
time frame: 30 days
description: Change in plasma CTX
measure: Change in plasma P1NP
time frame: 30 days
description: Change in plasma P1NP
measure: Occurence of thirst
time frame: 30 days
description: Occurence of thirst
measure: Occurence of headache
time frame: 30 days
description: Occurence of headache
measure: Occurence of vertigo
time frame: 30 days
description: Occurence of vertigo
measure: Occurence of nausea
time frame: 30 days
description: Occurence of nausea
measure: Change in general well-being
time frame: 30 days
description: Change in general well-being according to visual analogue scale
measure: Change in quality of life
time frame: 30 days
description: change in quality of life according to EQ-5D-5L questionnaire
measure: Change in cognitive impairment
time frame: 30 days
description: Change in cognitive impairment measured with the MoCa test
measure: Change in visual attention
time frame: 30 days
description: Change in visual attention measured with the trail making test
measure: Change in neuromuscular impairment
time frame: 30 days
description: Change in neuromuscular impairment measured with the timed up and go test
measure: Change in grip strength
time frame: 30 days
description: Change in grip strength measured with a hand dynamometer
measure: Occurence of falls
time frame: 30 days
description: Occurence of falls
measure: Occurence of fractures
time frame: 30 days
description: Occurence of fractures
measure: Length of hospital stay
time frame: 30 days
description: Length of hospital stay
arm group label: Empagliflozin
arm group type: Experimental
description: Empagliflozin (Jardiance)® 25mg per os once daily for 30 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (Lactose tablet) per os once daily for 30 days
intervention type: Drug
intervention name: Empagliflozin 25 MG
description: Empagliflozin 25mg per os once daily for 30 days
arm group label: Empagliflozin
intervention type: Drug
intervention name: Placebo
description: Placebo per os once daily for 30 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie Refardt, MD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
last name: Mirjam Christ-Crain, Prof
phone: +41 61 328 70 80
email: Mirjam.Christ-Crain@usb.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Liver Failure
mesh term: Renal Insufficiency
mesh term: Hyponatremia
mesh term: Empagliflozin
sharing ipd: Yes