<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/NCT02238093</url>
  </required_header>
  <id_info>
    <org_study_id>106-13-HYMC</org_study_id>
    <nct_id>NCT02238093</nct_id>
  </id_info>
  <brief_title>Cardiorenal Syndrome in End-Stage Kidney Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients.&#xD;
      Recently, its prevalence is rising. There are several different clinical presentations of&#xD;
      this syndrome. It has a high rate of morbidity and mortality.&#xD;
&#xD;
      The purpose of this study is to find the connection between the heart pathology and its&#xD;
      effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these&#xD;
      patients, and hopefully, aid in increasing their quality of life, and decrease their&#xD;
      morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Pathology Identification</measure>
    <time_frame>One hour</time_frame>
    <description>Visual identification of heart pathology in ESRD patients using echocardiography by measuring the ejection fraction of the left-ventricle during the systolic and diastolic phases. Valvular pathology is measured by the size of the valve.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">270</enrollment>
  <condition>End-stage Renal Disease</condition>
  <condition>Cardiorenal Syndrome</condition>
  <condition>Heart Disease</condition>
  <arm_group>
    <arm_group_label>Dialysis Patients</arm_group_label>
    <description>End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  End-stage renal patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer patients&#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>Noa Berar-Yanay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Noa Berar-Yanay, MD</last_name>
    <phone>972-4-630-4115</phone>
    <email>noab@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</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>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Cardio-Renal Syndrome</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_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/NCT02238093
org study id: 106-13-HYMC
nct id: NCT02238093
lead sponsor: 
has dmc: Yes
Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients.
      Recently, its prevalence is rising. There are several different clinical presentations of
      this syndrome. It has a high rate of morbidity and mortality.

      The purpose of this study is to find the connection between the heart pathology and its
      effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these
      patients, and hopefully, aid in increasing their quality of life, and decrease their
      morbidity and mortality.
observational model: Case-Only
time perspective: Retrospective
measure: Heart Pathology Identification
time frame: One hour
description: Visual identification of heart pathology in ESRD patients using echocardiography by measuring the ejection fraction of the left-ventricle during the systolic and diastolic phases. Valvular pathology is measured by the size of the valve.
arm group label: Dialysis Patients
description: End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Noa Berar-Yanay, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Noa Berar-Yanay, MD
phone: 972-4-630-4115
email: noab@hy.health.gov.il
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
mesh term: Cardio-Renal Syndrome
mesh term: Heart Diseases
mesh term: Syndrome