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OpenTrials
Completed

NCT Number: NCT01823432

Genetic Risks for Bicuspid Aortic Valve Disease

Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but very little is known about the genetic causes or risk factors for adverse outcomes. Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to use individual genetic information to identify persons with BAV who are at high risk for complications and to customize therapies.

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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 Unicuspid Aortic Valve

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

About this study

To be included in the study, patients must have a bicuspid or unicuspid aortic valve, documented by clinical history or imaging studies. If the aortic valve was replaced surgically, they may still be eligible. Participants will be asked to donate a single tube of blood and fill out a questionnaire. Patients will also be followed up by telephone or email about once a year to determine if they experience any medical complications related to Bicuspid Aortic Valve (BAV), such as aortic aneurysms, aortic dissections or valve disease. Patients may not be included if they are less than 18 years old at the time of recruitment or have a recognized genetic syndrome or genetic mutation such as Marfan or Ehlers-Danlos syndrome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age
  • Diagnosis of bicuspid or unicuspid aortic valve

Exclusion criteria

  • Less than 18 years of age
  • Recognized syndrome or identified genetic mutation

Treatment and study plan

Primary outcomes

  1. Thoracic aortic aneurysms and dissections

    Time frame: 10 years

    Development of new aneurysms and/or dissections of the thoracic aorta

  2. Aortic valve replacement surgery

    Time frame: 10 years

Secondary outcomes

  1. Aortic enlargement

    Time frame: 10 years

    Dilation of thoracic aorta, new or progressive

Other outcomes

  1. Aortic valve degeneration

    Time frame: 10 years

    Increase in valve degeneration score by at least 1 unit

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2013
Registry last updated
Sep 21, 2022

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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