<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/NCT02994485</url>
  </required_header>
  <id_info>
    <org_study_id>Nadia Elwan</org_study_id>
    <nct_id>NCT02994485</nct_id>
  </id_info>
  <brief_title>Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin</brief_title>
  <official_title>Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Portal hypertension is not a disease in itself. Rather, it is an indication of an illness,&#xD;
      caused mostly by chronic lesions of the liver because of distinct causes, such as viral&#xD;
      infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic&#xD;
      vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal&#xD;
      hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by&#xD;
      more than 5 mm Hg.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C&#xD;
      infection, it may also reduce hepatic vascular resistance and portal pressure by improving&#xD;
      liver generation of nitric oxide and hepatic endothelial dysfunction in patients with&#xD;
      cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve&#xD;
      survival of patients with cirrhosis after variceal bleeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients with Reduced Portal Pressure After Intervention</measure>
    <time_frame>6 Months</time_frame>
    <description>the number of Patients with Reduced Portal Pressure After Intervention</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Portal Hypertension</condition>
  <arm_group>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin</intervention_name>
    <description>Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <other_name>Corvast</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe,&#xD;
             attenuated hepatic veins)&#xD;
&#xD;
          -  Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly,&#xD;
             ascites and encephalopathy grade I-II)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hepatic encephalopathy grade III-IV&#xD;
&#xD;
          -  Hepatocellular carcinoma&#xD;
&#xD;
          -  Treatment with statins in the previous 3 months&#xD;
&#xD;
          -  Hypersensitivity to statins&#xD;
&#xD;
          -  Previous surgical shunt or TIPS&#xD;
&#xD;
          -  Treatment with calcium channel blockers&#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>NADIA ELWAN, PROFESSOR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta university hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>RAAFAT SALAH, PROFESSOR</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta university hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MANAL HAMISA, Ass Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta university hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>EBTESAM A SHADY, BACHELOR</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta University hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>March 7, 2018</last_update_submitted>
  <last_update_submitted_qc>March 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Portal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simvastatin</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/NCT02994485
org study id: Nadia Elwan
nct id: NCT02994485
lead sponsor: 
has dmc: Yes
Portal hypertension is not a disease in itself. Rather, it is an indication of an illness,
      caused mostly by chronic lesions of the liver because of distinct causes, such as viral
      infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic
      vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal
      hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by
      more than 5 mm Hg.
Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C
      infection, it may also reduce hepatic vascular resistance and portal pressure by improving
      liver generation of nitric oxide and hepatic endothelial dysfunction in patients with
      cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve
      survival of patients with cirrhosis after variceal bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Patients with Reduced Portal Pressure After Intervention
time frame: 6 Months
description: the number of Patients with Reduced Portal Pressure After Intervention
arm group label: Simvastatin
arm group type: Active Comparator
description: Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks
arm group label: no treatment
arm group type: No Intervention
description: no treatment
intervention type: Drug
intervention name: Simvastatin
description: Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment
arm group label: Simvastatin
other name: Corvast
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: NADIA ELWAN, PROFESSOR
role: Principal Investigator
affiliation: Tanta university hospital
last name: RAAFAT SALAH, PROFESSOR
role: Study Chair
affiliation: Tanta university hospital
last name: MANAL HAMISA, Ass Prof
role: Study Chair
affiliation: Tanta university hospital
last name: EBTESAM A SHADY, BACHELOR
role: Study Chair
affiliation: Tanta University hospital
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Principle investigator
mesh term: Hypertension, Portal
mesh term: Simvastatin
sharing ipd: Undecided