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Trial record 22 of 52 for:    TIMP2

The Effect of Losartan in Bicuspid Aortic Valve Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01390181
Recruitment Status : Terminated (Due to low enrollment the decision was made to terminate study prior to final data collection for any individual.)
First Posted : July 8, 2011
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Anna Booher, University of Michigan

Brief Summary:

The specific aims of this study are to:

  • Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements >40mm.
  • Assess the effect on MMP levels during treatment with losartan, an angiotensin II receptor blocking agent.
  • In the setting of losartan therapy for one year, evaluate the response of MMP levels in these patients, and clinical outcomes including effects on aortic growth rate

Condition or disease Intervention/treatment Phase
Bicuspid Aortic Valve Thoracic Aortic Aneurysm Drug: Cozaar Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients
Study Start Date : September 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Losartan Drug: Cozaar
Angiotensin II Receptor Blocker
Other Name: Losartan

Primary Outcome Measures :
  1. Inflammatory Markers Levels [ Time Frame: Baseline and 12 months ]
    Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), & Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults >age 18 years and < 65 years old
  • Able to give informed consent
  • Presence of a bicuspid aortic valve (functional or true bicommisural)and ascending aorta or sinus of Valsalva >4.0cm
  • No contraindications to treatment with Losartan, an Angiotensin II receptor blocker
  • Able to safely participate in a 4 week drug washout period if currently taking an angiotensin II receptor blocker or ACE inhibitor.

Exclusion Criteria:

  • Unable to safely take losartan due to one or more of the following:

    • Hypersensitivity to losartan or other angiotensin receptor blockers
    • Pregnancy
    • Nursing mothers
    • History of angioedema
    • Hypotension - chronically volume depleted patients
    • Hepatic or renal impairment (Cr>1.5mg/dL)
    • Hyperkalemia (K+>4.8)
    • Renal artery stenosis
    • Severe congestive heart failure (class III-IV)
    • Currently taking potassium supplements or salt substitutes containing potassium
    • Currently taking lithium
  • Prior surgical intervention to aorta or aortic valve
  • Unable or unwilling to give informed consent and follow up with study activities
  • Currently taking an angiotensin receptor blocker or ACE inhibitor specifically for hypertension and are therefore unable to or are unwilling to participate in a 4 week drug washout period.
  • Females of child bearing who are unwilling to practice adequate birth control throughout the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01390181

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Anna Booher, MD University of Michigan

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Responsible Party: Anna Booher, MD, University of Michigan Identifier: NCT01390181     History of Changes
Other Study ID Numbers: HUM00048364
First Posted: July 8, 2011    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Thoracic
Heart Valve Diseases
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action