<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/NCT04455464</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-Cirrhosis-33</org_study_id>
    <nct_id>NCT04455464</nct_id>
  </id_info>
  <brief_title>Effect of Midodrine on HVPG in Advanced Chronic Liver Disease</brief_title>
  <official_title>Effect of Midodrine on HVPG in Advanced Chronic Liver Disease - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</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>
      -  Primary objective: HVPG response after administration of midodrine as defined by&#xD;
           decrease in HVPG by &gt; 20 % from baseline or to less than equals to 12 mmHg.&#xD;
&#xD;
        -  Secondary objectives: Change in HVPG, SVR, heart rate, cardiac output, cardiac index,&#xD;
           Blood pressure (systolic, diastolic and mean).&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      Consecutive patients of chronic liver disease in the Institute (admitted or coming to OPD) as&#xD;
      per the inclusion and exclusion criteria will be studied.&#xD;
&#xD;
        -  Study Population: Patients of advanced chronic liver disease admitted or OPD patients in&#xD;
           ILBS&#xD;
&#xD;
        -  Study Design: A single arm interventional study&#xD;
&#xD;
        -  Study Period: 6 months&#xD;
&#xD;
        -  Inclusion Criteria: i) CLD with grade III ascites with Na &lt; 130 / Systolic BP &lt; 90 /&#xD;
           type 2 HRS(n=30 ) (ii) ACLF (APASL criteria) with Na &lt; 130 / Systolic BP &lt; 90 / AKI&#xD;
           (n=30)&#xD;
&#xD;
        -  Exclusion Criteria: age &lt; 18 and &gt; 75, pregnancy, splanchnic venous thrombosis, HCC, HE,&#xD;
           significant cardiopulmonary disease, uncontrolled diabetes, hypertension, intrinsic&#xD;
           renal disease, peripheral vascular disease.&#xD;
&#xD;
        -  Sample Size with justification: This is a pilot study where a total of 60 patients will&#xD;
           be enrolled - 30 each in the two groups.&#xD;
&#xD;
        -  Intervention: HVPG will be done in these patients at baseline and then after 3 hours of&#xD;
           10 mg of midodrine tablets.&#xD;
&#xD;
      Monitoring and assessment: Various parameters will be assessed during the procedure before&#xD;
      and after 3 hours of midodrine such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output,&#xD;
      cardiac index, Blood pressure (systolic, diastolic and mean), SpO2.&#xD;
&#xD;
      - Statistical Analysis: Continuous data will be represented by mean ± SD or median ± IQR.&#xD;
      Categorical data will be represented by n = frequency (%). Categorical data will be analyzed&#xD;
      by Chi square test or Fisher exact test as appropriate. Continuous data will be compared by&#xD;
      using student t test or Mann Whitney test (when applicable). The change in HVPG will be&#xD;
      analyzed by using paired t test or Wilcoxon signed rank test. The % change in the individual&#xD;
      group will be compared to see the significance between the groups. The significance will be&#xD;
      seen at 5%.&#xD;
&#xD;
        -  Adverse Effects: same as for HVPG (mild pain / hematoma at the puncture site, transient&#xD;
           arrhythmias). Midodrine has got good safety profile and is used in patients of advanced&#xD;
           chronic liver disease.&#xD;
&#xD;
        -  Stopping Rule of study: nil&#xD;
&#xD;
      Expected outcome of the project: If result shows that HVPG is decreased by midodrine, then it&#xD;
      can be used in place of beta blockers when they are contraindicated or have the potential of&#xD;
      causing adverse effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2020</start_date>
  <completion_date type="Actual">December 13, 2021</completion_date>
  <primary_completion_date type="Actual">December 13, 2021</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>HVPG response after administration of midodrine as defined by decrease in HVPG by &gt; 20 % from baseline or to less than equals to 12 mmHg</measure>
    <time_frame>3 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hepatic Venous Pressure Gradient.</measure>
    <time_frame>3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systemic Vascular Resistance.</measure>
    <time_frame>3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Heart Rate.</measure>
    <time_frame>3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cardiac Output.</measure>
    <time_frame>3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Blood pressure (Systolic, Diastolic and Mean).</measure>
    <time_frame>3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cardiac Index.</measure>
    <time_frame>3 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Liver Disease</condition>
  <arm_group>
    <arm_group_label>Midodrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Midodrine will be given 10 mg for one time only. HVPG will be done at baseline and after 3 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midodrine Oral Tablet</intervention_name>
    <description>Midodrine will be given 10 mg for one time only.</description>
    <arm_group_label>Midodrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - i) CLD with grade III ascites with Na &lt; 130 / Systolic BP &lt; 90 / type 2 HRS(n=30 ) ii)&#xD;
        ACLF (APASL criteria) with Na &lt; 130 / Systolic BP &lt; 90 / AKI (n=30)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age &lt; 18 and &gt; 75,&#xD;
&#xD;
          2. Pregnancy,&#xD;
&#xD;
          3. Splanchnic venous thrombosis,&#xD;
&#xD;
          4. Hepatocellular Carcinoma,&#xD;
&#xD;
          5. Hepaticencephalopathy,&#xD;
&#xD;
          6. Significant cardiopulmonary disease,&#xD;
&#xD;
          7. Uncontrolled diabetes,&#xD;
&#xD;
          8. Hypertension,&#xD;
&#xD;
          9. Intrinsic renal disease,&#xD;
&#xD;
         10. Peripheral vascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</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 Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midodrine</mesh_term>
  </intervention_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/NCT04455464
org study id: ILBS-Cirrhosis-33
nct id: NCT04455464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
-  Primary objective: HVPG response after administration of midodrine as defined by
           decrease in HVPG by > 20 % from baseline or to less than equals to 12 mmHg.

        -  Secondary objectives: Change in HVPG, SVR, heart rate, cardiac output, cardiac index,
           Blood pressure (systolic, diastolic and mean).

      Methodology:

      Consecutive patients of chronic liver disease in the Institute (admitted or coming to OPD) as
      per the inclusion and exclusion criteria will be studied.

        -  Study Population: Patients of advanced chronic liver disease admitted or OPD patients in
           ILBS

        -  Study Design: A single arm interventional study

        -  Study Period: 6 months

        -  Inclusion Criteria: i) CLD with grade III ascites with Na < 130 / Systolic BP < 90 /
           type 2 HRS(n=30 ) (ii) ACLF (APASL criteria) with Na < 130 / Systolic BP < 90 / AKI
           (n=30)

        -  Exclusion Criteria: age < 18 and > 75, pregnancy, splanchnic venous thrombosis, HCC, HE,
           significant cardiopulmonary disease, uncontrolled diabetes, hypertension, intrinsic
           renal disease, peripheral vascular disease.

        -  Sample Size with justification: This is a pilot study where a total of 60 patients will
           be enrolled - 30 each in the two groups.

        -  Intervention: HVPG will be done in these patients at baseline and then after 3 hours of
           10 mg of midodrine tablets.

      Monitoring and assessment: Various parameters will be assessed during the procedure before
      and after 3 hours of midodrine such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output,
      cardiac index, Blood pressure (systolic, diastolic and mean), SpO2.

      - Statistical Analysis: Continuous data will be represented by mean ± SD or median ± IQR.
      Categorical data will be represented by n = frequency (%). Categorical data will be analyzed
      by Chi square test or Fisher exact test as appropriate. Continuous data will be compared by
      using student t test or Mann Whitney test (when applicable). The change in HVPG will be
      analyzed by using paired t test or Wilcoxon signed rank test. The % change in the individual
      group will be compared to see the significance between the groups. The significance will be
      seen at 5%.

        -  Adverse Effects: same as for HVPG (mild pain / hematoma at the puncture site, transient
           arrhythmias). Midodrine has got good safety profile and is used in patients of advanced
           chronic liver disease.

        -  Stopping Rule of study: nil

      Expected outcome of the project: If result shows that HVPG is decreased by midodrine, then it
      can be used in place of beta blockers when they are contraindicated or have the potential of
      causing adverse effects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HVPG response after administration of midodrine as defined by decrease in HVPG by > 20 % from baseline or to less than equals to 12 mmHg
time frame: 3 hours
measure: Change in Hepatic Venous Pressure Gradient.
time frame: 3 hours
measure: Change in Systemic Vascular Resistance.
time frame: 3 hours
measure: Change in Heart Rate.
time frame: 3 hours
measure: Change in Cardiac Output.
time frame: 3 hours
measure: Change in Blood pressure (Systolic, Diastolic and Mean).
time frame: 3 hours
measure: Change in Cardiac Index.
time frame: 3 hours
arm group label: Midodrine
arm group type: Experimental
description: Midodrine will be given 10 mg for one time only. HVPG will be done at baseline and after 3 hours
intervention type: Drug
intervention name: Midodrine Oral Tablet
description: Midodrine will be given 10 mg for one time only.
arm group label: Midodrine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Midodrine
sharing ipd: Undecided