Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bicuspid Aortic Valve
- Sponsor
- Oregon Health and Science University
- Enrollment
- 500
- Locations
- 6
- Primary Endpoint
- Change in aortic area measured by MRI
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Craig Broberg
Associate Professor
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- •Bicuspid aortic valve
- •Aortic measurement of 35 - 49 mm on prior imaging study
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in aortic area measured by MRI
Time Frame: 24 months
Patients will have a baseline and follow up MRI per a specific protocol to measure area of the ascending thoracic aorta. All measurements will be performed by a core imaging lab
Secondary Outcomes
- Clinical events involving the aorta, including change in medical therapy(24 months)