<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/NCT01670903</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-12-8336-DS-CTIL</org_study_id>
    <nct_id>NCT01670903</nct_id>
  </id_info>
  <brief_title>The Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients</brief_title>
  <official_title>the Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the&#xD;
      aortic wall. The natural history of AAA is gradual expansion and if left untreated may result&#xD;
      in rupture and death. The mechanism of the development of this disease is unknown however it&#xD;
      appears to be multifactorial and possibly related to degradation processes within the&#xD;
      arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may have&#xD;
      an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting&#xD;
      degeneration of the vessel wall.&#xD;
&#xD;
      Study hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive&#xD;
      patients, and are associated with a lower rate of aortic expansion compared to other&#xD;
      antihypertensive drugs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2011</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Aneurysm</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>ARBs</arm_group_label>
    <description>Hypertensive patients treated with ARBs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACE inhibitors</arm_group_label>
    <description>Hypertensive patients treated with ACE inhibitors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non ARB/ACE</arm_group_label>
    <description>Hypertensive patients treated with non ARBs or ACE inhibitors meds</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        medically treated hypertensive patients, ages 50-80&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medically treated hypertensive patients, ages 50-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  patients previously treated for aortic disease&#xD;
&#xD;
          -  unable to sign informed consent, minors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Silverberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Silverberg, MD</last_name>
    <phone>035302712</phone>
    <email>Daniel.Silverberg@sheba.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jacob Schneiderman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ehud Grossman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Moshe Halak, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anan Younes, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dmitry Yakubovitz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bashir Sheik-yosef, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ronnie E Reinitz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Silverberg, MD</last_name>
      <email>Daniel.Silverberg@sheba.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 19, 2012</last_update_submitted>
  <last_update_submitted_qc>August 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Daniel Silverberg</investigator_full_name>
    <investigator_title>Senior consultant - Vascular surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</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/NCT01670903
org study id: SHEBA-12-8336-DS-CTIL
nct id: NCT01670903
lead sponsor: 
has dmc: No
Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the
      aortic wall. The natural history of AAA is gradual expansion and if left untreated may result
      in rupture and death. The mechanism of the development of this disease is unknown however it
      appears to be multifactorial and possibly related to degradation processes within the
      arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may have
      an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting
      degeneration of the vessel wall.

      Study hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive
      patients, and are associated with a lower rate of aortic expansion compared to other
      antihypertensive drugs.
observational model: Cohort
time perspective: Prospective
arm group label: ARBs
description: Hypertensive patients treated with ARBs
arm group label: ACE inhibitors
description: Hypertensive patients treated with ACE inhibitors
arm group label: non ARB/ACE
description: Hypertensive patients treated with non ARBs or ACE inhibitors meds
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Daniel Silverberg, MD
role: Principal Investigator
affiliation: Sheba Medical Center
last name: Daniel Silverberg, MD
phone: 035302712
email: Daniel.Silverberg@sheba.health.gov.il
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Daniel Silverberg
investigator title: Senior consultant - Vascular surgery
mesh term: Aneurysm