International Bicuspid Aortic Valve Consortium (BAVCon)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 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: February 2, 2015
Last verified: February 2015
  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   
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Gordon Huggins, MD    617-636-2807    ghuggins@tuftsmedicalcenter.org   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Anna Booher, MD    734-998-7955    amanion@med.umich.edu   
Contact: Mike Ranella    734-232-4128    ranellam@med.umich.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Hector Michelena, MD    507-284-3687    michelena.hector@mayo.edu   
Contact: Maurice Sarano, MD, FACC, FAHA    507-284-2904    sarano.maurice@mayo.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Josh Denny, MD, MS    615-936-1556    josh.denny@vanderbilt.edu   
Contact: Emilia McCann    615-936-1542    emilia.mccann@vanderbilt.edu   
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Siddharth Prakash, MD, PhD    713-500-7003    Siddharth.K.Prakash@uth.tmc.edu   
Contact: Truc Baccam, RN    713-500-6715    Truc.Baccam@uth.tmc.edu   
Canada, Quebec
Laval University Recruiting
Quebec City, Quebec, Canada, G1V 4G5
Contact: Yohan Bossé, PhD    418-656-8711 ext 3725    yohan.bosse@criucpq.ulaval.ca   
Contact: Patrick Mathieu, MD, FRCSC    418-656-8711 ext 3173    patrick.mathieu@chg.ulaval.ca   
Italy
Istituto Policlinico San Donato Recruiting
San Donato Milanese, Milan, Italy, 20097
Contact: Alessandro Frigiola    39-0252774519    alessandro.frigiola@grupposandonato.it   
Contact: Francesca Pluchinotta, MD    39-0252774502    francesca.pluchinotta@grupposandonato.it   
Monaldi Hospital Recruiting
Naples, Italy, 80100
Contact: Giuseppe Limongelli, MD, PhD, FESC, FAHA    39-0817064050    limongelligiuseppe@libero.it   
Contact: Fiorella Fratta, MD    39 3384733322    fiorellafratta@hotmail.it   
Second University of Naples Recruiting
Naples, Italy, 80131
Contact: Alessandro Della Corte, MD, PhD    39 081 706 4020    aledellacorte@libero.it   
Contact: Ciro Bancone, MD, PhD    39 347 6268544    cirobancone@vodafone.it   
University of Salerno Recruiting
Salerno, Italy, 36-83023
Contact: Eduardo Bossone, MD, PhD    39-328-5415438    ebossone@hotmail.com   
Contact: Rodolfo Citro, MD, PhD    39 089 673377    rodolfocitro@gmail.com   
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Arturo Evangelista, MD       arturevangelistamasip@gmail.com   
United Kingdom
University of Oxford Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Malenka Bissell, MD, BM, MRCPCH    44 01865-221875    malenka.bissell@cardiov.ox.ac.uk   
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: February 2, 2015
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:
Aortic Diseases
Aortic Valve Stenosis
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Vascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on August 27, 2015