Bicuspid Valve Aortopathy Feasibility Study

Completed

Conditions studied: Bicuspid Aortic Valve

In brief

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.

Key facts

Study ID

NCT01920815

Run by

Oregon Health and Science University

People needed

500

Starts

2013-07-01

Expected to finish

2017-10-04

Last updated by the study team

2018-09-19

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bicuspid aortic valve
• Aortic measurement of 35 - 49 mm on prior imaging study

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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