Overview

This trial is active, not recruiting.

Condition bicuspid aortic valve
Treatment no interventions
Sponsor Oregon Health and Science University
Collaborator Emory University
Start date July 2013
End date May 2016
Trial size 500 participants
Trial identifier NCT01920815, 1R34HL115032-01A1--BAV, OHSU IRB 8330

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Cohort will consist of those actively taking any beta blocker medication. Observation only.
no interventions Observation only
Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only.
no interventions Observation only
Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only.
no interventions Observation only

Primary Outcomes

Measure
Change in aortic area measured by MRI
time frame: 24 months

Secondary Outcomes

Measure
Clinical events involving the aorta, including change in medical therapy
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.