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NCT01823432 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
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Active, not recruiting NCT03635424 - Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study N/A
Recruiting NCT06153407 - Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
Active, not recruiting NCT03474159 - Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve by Multimodal Imaging N/A
Not yet recruiting NCT06375590 - NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
Recruiting NCT05739253 - Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
Completed NCT02679261 - Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve Phase 3
Completed NCT01920815 - Bicuspid Valve Aortopathy Feasibility Study
Recruiting NCT04817735 - The CASPER Registry N/A
Recruiting NCT02899624 - Whole Exome Sequencing in Bicuspid Aortic Valve Patients N/A
Recruiting NCT05708118 - Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
Recruiting NCT03495050 - BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Completed NCT01760668 - Aortopathy in Persons With Bicuspid Aortic Valve, Turner and Marfan Syndrome N/A
Not yet recruiting NCT05711693 - Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV) N/A
Completed NCT05836363 - Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement
Completed NCT02283970 - Investigation of Patients With BAV Requiring Valve and/or Aortic Repair (GISSI Outliers VAR)
Active, not recruiting NCT01026571 - Identification of Genetic Causes of Bicuspid Aortic Valve Disease
Completed NCT00412386 - Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve N/A
Recruiting NCT03440697 - Pathogenetic Basis of Aortopathy and Aortic Valve Disease

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