<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/NCT01687699</url>
  </required_header>
  <id_info>
    <org_study_id>dohas01</org_study_id>
    <nct_id>NCT01687699</nct_id>
  </id_info>
  <brief_title>Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dialysis Outcomes Heart Failure Aldactone Study Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dialysis Outcomes Heart Failure Aldactone Study Group</source>
  <brief_summary>
    <textblock>
      Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we&#xD;
      demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis&#xD;
      (HD) patients. In the present study, we assess whether low-dose spironolactone treatment&#xD;
      reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD&#xD;
      patients. The investigators' hypothesis is that aldosterone receptor blockade by&#xD;
      spironolactone reduces the risk of both CCV morbidity and death among HD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2008</start_date>
  <primary_completion_date type="Actual">December 2008</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cardio- and cerebrovascular events</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>death from all causes</measure>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>End-stage Renal Failure</condition>
  <arm_group>
    <arm_group_label>spironolactone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spironolactone</intervention_name>
    <arm_group_label>spironolactone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years&#xD;
&#xD;
          -  With an average serum potassium level (immediately before dialysis on the first day of&#xD;
             the week) of &lt;6.5 mEq/l over the previous 2 months&#xD;
&#xD;
          -  With a 24-hour urine output of &lt;500 ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of noncompliance&#xD;
&#xD;
          -  Unstable vascular access&#xD;
&#xD;
          -  Hypotension&#xD;
&#xD;
          -  Hepatic failure&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Any life-threatening disease other than ESRD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Shibukawa Clinic</name>
      <address>
        <city>Shizuoka</city>
        <zip>424-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/19342857</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 14, 2012</last_update_submitted>
  <last_update_submitted_qc>September 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dialysis Outcomes Heart Failure Aldactone Study Group</investigator_affiliation>
    <investigator_full_name>Yoshihiro Matsumoto</investigator_full_name>
    <investigator_title>MD., PhD.</investigator_title>
  </responsible_party>
  <keyword>cardiovascular event</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>spironolactone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spironolactone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01687699
org study id: dohas01
nct id: NCT01687699
lead sponsor: 
Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we
      demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis
      (HD) patients. In the present study, we assess whether low-dose spironolactone treatment
      reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD
      patients. The investigators' hypothesis is that aldosterone receptor blockade by
      spironolactone reduces the risk of both CCV morbidity and death among HD patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: cardio- and cerebrovascular events
measure: death from all causes
arm group label: spironolactone
arm group type: Experimental
intervention type: Drug
intervention name: Spironolactone
arm group label: spironolactone
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
facility: 
country: Japan
url: http://www.ncbi.nlm.nih.gov/pubmed/19342857
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Dialysis Outcomes Heart Failure Aldactone Study Group
investigator full name: Yoshihiro Matsumoto
investigator title: MD., PhD.
mesh term: Kidney Failure, Chronic
mesh term: Spironolactone