Bicuspid Aortic Valve
Conditions
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.
Interventions
OTHERNo interventions
Sponsors
Emory University
University of Colorado, Denver
Baylor College of Medicine
University of California, Los Angeles
Penn State University
Oregon Health and Science University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed