International Bicuspid Aortic Valve Consortium (BAVCon)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Simon Body, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01980797
First received: November 5, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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
Bicuspid Aortic Valve Disease
Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: International Bicuspid Aortic Valve Consortium (BAVCon)

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Bicuspid aortic valve disease [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    The first specific aim is to identify the genetic causes of bicuspid aortic valve disease.


Secondary Outcome Measures:
  • The development of thoracic aortic disease in patients with bicuspid aortic valve disease [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10000
Study Start Date: November 2013
Estimated Study Completion Date: November 2033
Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980797

Contacts
Contact: Simon C Body, MD MPH 617-732-8127 sbody@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Simon C Body, MD MPH    617-732-8127      
Contact: Michael Franke, MD MPH    617-732-8127    mfrancke@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Study Chair: Simon C Body, MD MPH Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Simon Body, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01980797     History of Changes
Other Study ID Numbers: 2013P000260
Study First Received: November 5, 2013
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Bicuspid aortic valve disease
Thoracic aortic disease
Genetics
Echocardiography
Cardiac CT
Cardiac MRI

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Aortic Valve Stenosis
Aortic Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ventricular Outflow Obstruction
Vascular Diseases

ClinicalTrials.gov processed this record on October 02, 2014