Clinical Trial: International Bicuspid Aortic Valve Consortium (BAVCon)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: International Bicuspid Aortic Valve Consortium (BAVCon)
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:
- To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.
- 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.
Detailed Summary:
The International Bicuspid Aortic Valve Consortium (BAVCon) Registry is the data collection arm of the International Bicuspid Aortic Valve Consortium, a 16 institution international consortium of investigators with interests in the genetics, molecular biology, imaging, surgery and natural history of bicuspid aortic valve disease.
The BAVCon Registry is a longitudinal cohort study, which is observational by design. The cohort will consist of patients with BAV. Consideration will be given to eventual inclusion of a disease-free control or comparison group. The study will compare genetic risk factors, cross-sectional and longitudinal data on risk factors related to the diagnosis, treatment and outcomes among groups of enrolled patients. As part of the natural course of clinical care, the patients and their physicians will determine the approach to treatment and the study will record the observed related outcomes. The study will not attempt to interfere with the outcomes through any type of planned intervention; therefore, there are no anticipated adverse events as a result of study participation.
Study Design
The Registry is designed to capture information on patients with bicuspid aortic valve disease. The BAVCon Registry population will be comprised of patients from sixteen BAVCon Clinical Centers. The participating BAVCon Clinical Centers are:
- Harvard University / Partners Healthcare, Boston (Dr. Simon Body, Consortium PI)
- GenTAC Consortium (Dr. Kim Eagle, PI)
- Hospital Vall d'Hebron, Barcelona, Spain (Dr. Arturo Evangelista, PI)
- Monaldi Hospital, Naples, Italy (Dr. Giuseppe Limongelli, PI)<
Sponsor: Brigham and Women's Hospital
Current Primary Outcome: Bicuspid aortic valve disease [ Time Frame: 10 years ]
The first specific aim is to identify the genetic causes of bicuspid aortic valve disease.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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.
Original Secondary Outcome: Same as current
Information By: Brigham and Women's Hospital
Dates:
Date Received: November 5, 2013
Date Started: November 2013
Date Completion: November 2033
Last Updated: July 20, 2016
Last Verified: July 2016
