Bicuspid Valve Aortopathy Feasibility Study

Oregon Health & Science University (OHSU)

Status

Completed

Conditions

Bicuspid Aortic Valve

Treatments

Other: No interventions

Study type

Observational

Funder types

Other

Identifiers

NCT01920815

1R34HL115032-01A1--BAV

OHSU IRB 8330

1R34HL115032-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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