Genetic Risks for Bicuspid Aortic Valve Disease

Bicuspid Aortic Valve Clinical Trial

Official title:

Genetic Risks for Bicuspid Aortic Valve Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823432
• Other study ID #: HSC-MS-11-0185
• Status: Completed
• Start date: March 2012
• Est. completion date: September 19, 2022

Study information

• Verified date: September 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Bicuspid Aortic Valve
• Bicuspid Aortic Valve Disease
• Heart Valve Diseases
• Unicuspid Aortic Valve

Locations

Country	Name	City	State
United States	University of Texas Health Science Center Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aortic valve degeneration	Increase in valve degeneration score by at least 1 unit	10 years
Primary	Thoracic aortic aneurysms and dissections	Development of new aneurysms and/or dissections of the thoracic aorta	10 years
Primary	Aortic valve replacement surgery		10 years
Secondary	Aortic enlargement	Dilation of thoracic aorta, new or progressive	10 years

External Links

•   John Ritter Research Program in Aortic and Vascular Disease