Bicuspid Aortic ValveNCT01920815
Bicuspid Valve Aortopathy Feasibility Study
An observational study of Bicuspid Aortic Valve, run by Oregon Health and Science University at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bicuspid Aortic Valve
- How many people
- 500 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2013to 4 Oct 2017
- How long will I take part?
- 24 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a bicuspid aortic valve.
Who may be able to join
- Bicuspid aortic valve
- Aortic measurement of 35 - 49 mm on prior imaging study
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia
University of Colorado
Denver, Colorado
Penn State
Hershey, Pennsylvania
Baylor College of Medicine
Houston, Texas
University of California
Los Angeles, California
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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.
- Conditions
- Bicuspid Aortic Valve
- Being tested
- No interventions
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
Also called Observation only
| Study group | Role | What they receive |
|---|---|---|
| Beta blocker therapy | Cohort will consist of those actively taking any beta blocker medication. Observation only. Receives: Other: No interventions | |
| ARB therapy | Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only. Receives: Other: No interventions | |
| No therapy | Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicuspid Aortic ValveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, University of Colorado, Denver, Baylor College of Medicine, University of California, Los Angeles, Penn State University
- Responsible party
- Principal investigator, Craig Broberg, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920815
- Sponsor's protocol ID
- 1R34HL115032-01A1--BAV
- Other IDs
- OHSU IRB 8330, 1R34HL115032-01A1
- Status last verified
- Sep 2018
- First submitted
- 8 Aug 2013
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No