Bicuspid Valve Aortopathy Feasibility Study

Completed

• Conditions: Bicuspid Aortic Valve
• Interventions: Other: No interventions

• Registration Number: NCT01920815
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-12
• Primary Completion: 2016-06
• Study Completion: 2017-10-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No therapy	No interventions	Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only.
Beta blocker therapy	No interventions	Cohort will consist of those actively taking any beta blocker medication. Observation only.
ARB therapy	No interventions	Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only.

Primary Outcome Measures

Name	Time	Method
Change in aortic area measured by MRI	24 months	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

Secondary Outcome Measures

Name	Time	Method
Clinical events involving the aorta, including change in medical therapy	24 months	We will observe for any major clinical events over time such as need for surgery, as well as changes in medical therapy over time.

Trial Locations

Locations (6)

University of California; 🇺🇸 Los Angeles, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Penn State; 🇺🇸 Hershey, Pennsylvania, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States