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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU IRB 8330 | |||
| 1R34HL115032-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| University of Colorado, Denver | OTHER |
| Baylor College of Medicine | OTHER |
| University of California, Los Angeles |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta blocker therapy | Cohort will consist of those actively taking any beta blocker medication. Observation only. |
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| ARB therapy | Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only. |
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| No therapy | Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions | Other |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a bicuspid aortic valve.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Los Angeles | California | United States | |||
| University of Colorado |
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| ID | Term |
|---|---|
| D000082882 | Bicuspid Aortic Valve Disease |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| OTHER |
| Penn State University | OTHER |
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| Denver |
| Colorado |
| United States |
| Emory University | Atlanta | Georgia | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Penn State | Hershey | Pennsylvania | United States |
| Baylor College of Medicine | Houston | Texas | United States |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |