Bicuspid Valve Aortopathy Feasibility Study
- Conditions
- Bicuspid Aortic Valve
- Registration Number
- NCT01920815
- Lead Sponsor
- Oregon Health and Science University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in aortic area measured by MRI 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 Outcome Measures
Name Time Method Clinical events involving the aorta, including change in medical therapy 24 months We will observe for any major clinical events over time such as need for surgery, as well as changes in medical therapy over time.
Trial Locations
- Locations (6)
University of California
🇺🇸Los Angeles, California, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Penn State
🇺🇸Hershey, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of California🇺🇸Los Angeles, California, United States