Bicuspid Valve Aortopathy Feasibility Study

Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study

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.

Study Overview

• Status: Completed
• Conditions: Bicuspid Aortic Valve
• Intervention / Treatment: Other: No interventions

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States
      • University of California
  • Colorado
    • Denver, Colorado, United States
      • University of Colorado
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States
      • Penn State
  • Texas
    • Houston, Texas, United States
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a bicuspid aortic valve.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Beta blocker therapy; Cohort will consist of those actively taking any beta blocker medication. Observation only.	Other: No interventions; Other Names: Observation only
ARB therapy; Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only.	Other: No interventions; Other Names: Observation only
No therapy; Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only.	Other: No interventions; Other Names: Observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of Colorado, Denver; Baylor College of Medicine; University of California, Los Angeles; Emory University; Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): October 4, 2017

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 9, 2013
• First Posted (Estimate): August 12, 2013

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Aortic Valve Disease; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Bicuspid Aortic Valve Disease
• Other Study ID Numbers: 1R34HL115032-01A1--BAV; OHSU IRB 8330; 1R34HL115032-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO