Bicuspid Valve Aortopathy Feasibility Study

N/ACompletedNCT01920815

Oregon Health and Science University500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Bicuspid Aortic Valve

Interventions

No interventionsOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 24 months

Data from ClinicalTrials.gov

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