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International Bicuspid Aortic Valve Consortium (BAVCon) (BAVCon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01980797
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : November 11, 2013
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

Brief Summary:

Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability.

The Specific Aims of this study are:

  1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.
  2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease.

To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.


Condition or disease
Bicuspid Aortic Valve Disease Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: International Bicuspid Aortic Valve Consortium (BAVCon)
Study Start Date : November 2013
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2033

Group/Cohort
Bicuspid aortic valve disease

Group/Cohort Label - Bicuspid aortic valve

Group/Cohort Description -

  • Patients diagnosed with bicuspid aortic valve
  • All ages ≥8 years
  • Able to provide fully informed consent
Tricuspid aortic valve control patients

Group/Cohort Label - Tricuspid aortic valve control patients

Group/Cohort Description -Control patients will come from approximately matched patients without an identified bicuspid aortic valve who are trace, gender and geographically matched.

  • Patients not diagnosed with bicuspid aortic valve
  • All ages ≥8 years
  • Able to provide fully informed consent



Primary Outcome Measures :
  1. Bicuspid aortic valve disease [ Time Frame: 10 years ]
    The first specific aim is to identify the genetic causes of bicuspid aortic valve disease.


Secondary Outcome Measures :
  1. The development of thoracic aortic disease in patients with bicuspid aortic valve disease [ Time Frame: 10 years ]
    The second specific aim is to identify genetic and non-genetic factors to cause thoracic aortic disease in BAV patients.


Biospecimen Retention:   Samples With DNA
We are collecting DNA from either saliva or blood.


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with and without bicuspid aortic valves disease
Criteria

Inclusion Criteria:

  • Patients diagnosed as having a bicuspid aortic valve
  • All ages ≥8 years
  • Able to provide fully informed consent

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980797


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Canada, Quebec
Laval University
Quebec City, Quebec, Canada, G1V 4G5
Italy
Istituto Policlinico San Donato
San Donato Milanese, Milan, Italy, 20097
Monaldi Hospital
Naples, Italy, 80100
Second University of Naples
Naples, Italy, 80131
University of Salerno
Salerno, Italy, 36-83023
Spain
Hospital Vall d'Hebron
Barcelona, Spain, 08035
United Kingdom
University of Oxford
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Simon C. Robson, MD, PhD Beth Israel Deaconess Medical Center
Additional Information:
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01980797    
Other Study ID Numbers: 2013P000260
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Keywords provided by Beth Israel Deaconess Medical Center:
Bicuspid aortic valve disease
Thoracic aortic disease
Genetics
Echocardiography
Cardiac CT
Cardiac MRI
Additional relevant MeSH terms:
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Heart Valve Diseases
Aortic Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases