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Completed

NCT Number: NCT01920815

Bicuspid Valve Aortopathy Feasibility 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.

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Key information

Conditions

Bicuspid Aortic Valve Aortic Valve Disease Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

Other names: Observation only

Primary outcomes

  1. Change in aortic area measured by MRI

    Time frame: 24 months

    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

Secondary outcomes

  1. Clinical events involving the aorta, including change in medical therapy

    Time frame: 24 months

    We will observe for any major clinical events over time such as need for surgery, as well as changes in medical therapy over time.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Baylor College of Medicine
  • Emory University
  • Penn State University
  • University of California, Los Angeles
  • University of Colorado, Denver

Registry information

Official study title

Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Aug 12, 2013
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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