The Effect of Losartan in Bicuspid Aortic Valve Patients
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
U.S. FDA Resources
Angiotensin II Receptor Blocker
Other Name: Losartan
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01390181
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Anna Booher, MD||University of Michigan|