Bicuspid Valve Aortopathy Feasibility Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study

Conditions
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Bicuspid Aortic Valve

Intervention / Treatment
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* Other: No interventions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Beta blocker therapy<br>Cohort will consist of those actively taking any beta blocker medication. Observation only. | Other: No interventions<br> <br> * Other names: Observation only;|
| ARB therapy<br>Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only. | Other: No interventions<br> <br> * Other names: Observation only;|
| No therapy<br>Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only. | Other: No interventions<br> <br> * Other names: Observation only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aortic area measured by MRI | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical events involving the aorta, including change in medical therapy | We will observe for any major clinical events over time such as need for surgery, as well as changes in medical therapy over time. | 24 months |