- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823432
Genetic Risks for Bicuspid Aortic Valve Disease
September 19, 2022 updated by: Siddharth Prakash, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
454
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults at least 18 years old with unicuspid or bicuspid aortic valves
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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BAV Cohort
Patients with bicuspid or unicuspid aortic valves, regardless of surgical status.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thoracic aortic aneurysms and dissections
Time Frame: 10 years
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Development of new aneurysms and/or dissections of the thoracic aorta
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10 years
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Aortic valve replacement surgery
Time Frame: 10 years
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10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aortic enlargement
Time Frame: 10 years
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Dilation of thoracic aorta, new or progressive
|
10 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aortic valve degeneration
Time Frame: 10 years
|
Increase in valve degeneration score by at least 1 unit
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Siddharth Prakash, MD, PhD, The University of Texas Health Science Center, Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2012
Primary Completion (Actual)
September 19, 2022
Study Completion (Actual)
September 19, 2022
Study Registration Dates
First Submitted
March 27, 2013
First Submitted That Met QC Criteria
April 2, 2013
First Posted (Estimate)
April 4, 2013
Study Record Updates
Last Update Posted (Actual)
September 21, 2022
Last Update Submitted That Met QC Criteria
September 19, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-11-0185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bicuspid Aortic Valve
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Boston UniversityNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingBicuspid Aortic Valve Disease | Thoracic Aortic Disease in Patients With a Bicuspid Aortic ValveUnited States, Spain, United Kingdom, Canada, Italy
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St. George's Hospital, LondonCompletedThoracic Aortic Aneurysm | Bicuspid Cardiac ValveUnited Kingdom
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Oregon Health and Science UniversityUniversity of Colorado, Denver; Baylor College of Medicine; University of California... and other collaboratorsCompleted
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National University of Ireland, Galway, IrelandKarolinska University Hospital; Galway University Hospitals; Kerckhoff Heart... and other collaboratorsEnrolling by invitationAortic Stenosis | Transcatheter Aortic Valve Replacement | Bicuspid Aortic Valve | Transcatheter Aortic Valve ImplantationSweden, Ireland, Germany
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Institut für Pharmakologie und Präventive MedizinEdwards LifesciencesRecruitingAortic Stenosis With Bicuspid ValveItaly
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Clinique PasteurUnknownBicuspid Aortic ValveFrance
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University Hospitals, LeicesterRecruiting
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University of MichiganRecruiting
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University of CataniaNot yet recruitingAortic Stenosis | Bicuspid-related AortopathyItaly
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Gruppo di Ricerca GISSICompletedAortic Regurgitation | Bicuspid Aortic Valve | Aortic DilatationItaly