Biomarkers in Aortic Stenosis - B.A.S.S.

Location:

Rochester, Minn., Jacksonville, Fla.

Trial status:

Open for Enrollment

Why is this study being done?

Patients with aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads who are referred for clinically-indicated echocardiographic exams at Mayo Clinic, in Jacksonville, Florida will be screened for participation in the study. The plan is to have 292 people take part in this study. This minimal risk study will consist of the recording of patient data, activity and bleeding questionnaires, and collection and analysis of blood samples.  Each blood sample will be analyzed for von Willebrand Factor antigen and activity, and von Willebrand Factor multimers, and BNP. Blood samples will be sent to the Mayo Special Coagulation Lab for analysis.

     Objective:

     This study seeks to assess the degree of association of the von Willebrand Factor activity indices and BNP to the severity of cardiac lesions, and to note a relationship between acquired bleeding the the hematologic abnormalities.  Plasma will be stored in attempt to develop new in vitro tests of von Willebrand factor (VWF) activity.

Who is eligible to participate?

Inclusion Criteria:

         -  patients with mild, moderate, or severe aortic stenosis or aortic or mitral prosthesis. Patients with aortic or mitral regurgitation. patients with hypertrophic cardiomyopathy.  Patients with dysfunctional heart valve replacement or repair. Patients with severe tricuspid regurgitation associated with pacemaker or defibrillator lead. Ten normal control patients who will not be required to have echocardiography

         -  referred for a clinically indicated echocardiogram; the echo must be of good quality and specifically have patient height, weight, left ventricular outflow tract diameter, subaortic velocity profile by Doppler, and aortic transvalvular continuous wave Doppler velocity profile. For mitral regurgitation and aortic regurgitation the data must be adequate to allow calculation of regurgitant volume.  For hypertrophic cardiomyopathy, a recording of left ventricular outflow tract peak velocity must be recorded

         -  21 years or older

         -  patients with aortic stenosis, defined as peak aortic velocity greater than 2.5 m/sec with evidence of aortic valve thickening, or an aortic or mitral valve prosthesis

         -  able to provide written informed consent

       Exclusion Criteria:

         -  Missing or inadequate echocardiographic data

         -  inability to give informed consent

         -  inability to provide a research blood sample

         -  hemoglobin less than 8

         -  severe valvular regurgitation

         -  stenosis of the mitral valve

Last updated:

1/15/2013

NCT ID:

NCT01334801

IRB Number:

09-006757