Bicuspid Valve Aortopathy Feasibility Study
This trial is active, not recruiting.
|Condition||bicuspid aortic valve|
|Sponsor||Oregon Health and Science University|
|Start date||July 2013|
|End date||May 2016|
|Trial size||500 participants|
|Trial identifier||NCT01920815, 1R34HL115032-01A1--BAV, OHSU IRB 8330|
In order to determine the effectiveness of medical therapy options to prevent enlargement of the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This feasibility study will gather accurate data on number needed to screen, changes in medication use over time, and variance of the intended study endpoint.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Los Angeles, CA||University of California||no longer recruiting|
|Denver, CO||University of Colorado||no longer recruiting|
|Atlanta, GA||Emory University||no longer recruiting|
|Portland, OR||Oregon Health and Science University||no longer recruiting|
|Hershey, PA||Penn State||no longer recruiting|
|Houston, TX||Baylor College of Medicine||no longer recruiting|
Change in aortic area measured by MRI
time frame: 24 months
Clinical events involving the aorta, including change in medical therapy
time frame: 24 months
Male or female participants from 18 years up to 90 years old.
- Bicuspid aortic valve
- Aortic measurement of 35 - 49 mm on prior imaging study
- Prior aortic valve or thoracic aortic surgery
- Prior aortic dissection
- Other condition associated with enlarged aorta including Coarctation, Marfans, Turner syndrome, Loeys-Dietz, etc.
- Severe aortic stenosis or regurgitation
- Contraindication to MRI such as claustrophobia or implanted pacer/defibrillator
- Anticipated pregnancy, surgery, or move outside the area within 2 years
|Official title||Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study|
|Description||The study will consider all patients with a bicuspid aortic valve and 1) determine the number of patients needed to be screened for a clinical trial, based on patient eligibility percentages applying specific inclusion and exclusion criteria, 2) for those meeting these criteria, follow changes in and compliance with medical therapy over two years, and 3) in a limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the change in aortic area over time.|
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