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Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

Primary Purpose

Marfan Syndrome

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Coversyl (perindopril)
Sponsored by
Bayside Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Marfan Syndrome focused on measuring marfan syndrome, aortic root diameter

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-40
  • Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria

Exclusion Criteria:

  • Age <18, >40
  • Women of child-bearing potential not on adequate contraception
  • Serum creatinine of >0.11
  • A history of intolerance to ACEI
  • Patients on angiotensin receptor blockers
  • Blood pressure >140/90mmHg
  • History of previous aortic surgery

Sites / Locations

    Outcomes

    Primary Outcome Measures

    aortic root diameter

    Secondary Outcome Measures

    arterial stiffness

    Full Information

    First Posted
    June 11, 2007
    Last Updated
    June 12, 2007
    Sponsor
    Bayside Health
    Collaborators
    Baker Heart Research Institute, The Alfred
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00485368
    Brief Title
    Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome
    Official Title
    The Effect of an Angiotensin Converting Enzyme Inhibitor on Aortic Wall Properties in Patients With Marfan Syndrome.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bayside Health
    Collaborators
    Baker Heart Research Institute, The Alfred

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this research is to assess the effects of a drug called perindopril on the aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that comes out of the heart and supplies blood to the body. We know that in people with Marfan Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years. This enlargement of the aorta can be very serious. We know from treatment of other heart conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This type of drug has never been tried in people with Marfan Syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Marfan Syndrome
    Keywords
    marfan syndrome, aortic root diameter

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Coversyl (perindopril)
    Primary Outcome Measure Information:
    Title
    aortic root diameter
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    arterial stiffness
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-40 Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria Exclusion Criteria: Age <18, >40 Women of child-bearing potential not on adequate contraception Serum creatinine of >0.11 A history of intolerance to ACEI Patients on angiotensin receptor blockers Blood pressure >140/90mmHg History of previous aortic surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bronwyn A Kingwell, PhD
    Organizational Affiliation
    Baker Heart Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17911499
    Citation
    Ahimastos AA, Aggarwal A, D'Orsa KM, Formosa MF, White AJ, Savarirayan R, Dart AM, Kingwell BA. Effect of perindopril on large artery stiffness and aortic root diameter in patients with Marfan syndrome: a randomized controlled trial. JAMA. 2007 Oct 3;298(13):1539-47. doi: 10.1001/jama.298.13.1539.
    Results Reference
    derived

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    Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

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