Bicuspid Valve Aortopathy Feasibility Study

Bicuspid Aortic Valve Clinical Trial

Official title:

Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920815
• Other study ID #: 1R34HL115032-01A1--BAV
• Secondary ID: OHSU IRB 83301R3
• Status: Completed
• Start date: July 2013
• Est. completion date: October 4, 2017

Study information

• Verified date: September 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 4, 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bicuspid Aortic Valve

Intervention

Other:
• No interventions

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Oregon Health and Science University	Baylor College of Medicine, Emory University, Penn State University, University of California, Los Angeles, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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