Bicuspid Valve Aortopathy Feasibility Study

NCT ID: NCT01920815

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-10-04

Brief Summary

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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

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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

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Bicuspid Aortic Valve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Beta blocker therapy

Cohort will consist of those actively taking any beta blocker medication. Observation only.

No interventions

Intervention Type OTHER

ARB therapy

Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only.

No interventions

Intervention Type OTHER

No therapy

Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only.

No interventions

Intervention Type OTHER

Interventions

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No interventions

Intervention Type OTHER

Other Intervention Names

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Observation only

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Craig Broberg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California

Los Angeles, California, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Penn State

Hershey, Pennsylvania, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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OHSU IRB 8330

Identifier Type: -

Identifier Source: secondary_id

1R34HL115032-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R34HL115032-01A1--BAV

Identifier Type: -

Identifier Source: org_study_id

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