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The Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01670903
Collaborator
(none)
150
Enrollment
2
Locations
75
Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    the Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients
    Study Start Date :
    May 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    ARBs

    Hypertensive patients treated with ARBs
    ACE inhibitors

    Hypertensive patients treated with ACE inhibitors
    non ARB/ACE

    Hypertensive patients treated with non ARBs or ACE inhibitors meds

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      50 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • medically treated hypertensive patients, ages 50-80
      Exclusion Criteria:

      • pregnant women

      • patients previously treated for aortic disease

      • unable to sign informed consent, minors

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Sheba Medical Center Tel Hashomer Israel
      2 Sheba Medical Center Tel Hashomer Israel

      Sponsors and Collaborators

      • Sheba Medical Center

      Investigators

      • Principal Investigator: Daniel Silverberg, MD, Sheba Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Dr. Daniel Silverberg, Senior consultant - Vascular surgery, Sheba Medical Center
      ClinicalTrials.gov Identifier:
      NCT01670903
      Other Study ID Numbers:
      • SHEBA-12-8336-DS-CTIL
      First Posted:
      Aug 22, 2012
      Last Update Posted:
      Aug 22, 2012
      Last Verified:
      Aug 1, 2012
      Additional relevant MeSH terms:
      Aneurysm

      Study Results

      No Results Posted as of Aug 22, 2012