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

Completed

Conditions: Hypertrophic Cardiomyopathy
Aortic Valve Insufficiency
Tricuspid Valve Insufficiency
Aortic Stenosis
Mitral Valve Insufficiency
Disorder of Prosthetic Cardiac Valve

Brief Summary: This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the blood tests will be compared to the information from the clinically-indicated echocardiogram and one blood test compared to another.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Aortic regurgitation	Blood Draw	Echocardiographic and Doppler evaluation revealing aortic regurgitation with data adequate to calculate regurgitant volume
Severe TR with pacemaker / ICD lead	Blood Draw	Patients referred for clinically indicated echocardiography who have severe tricuspid regurgitation associated with a pacemaker or defibrillator lead documented by echocardiography
Prosthetic valve dysfunction	Blood Draw	Patients with prior heart valve replacement or repair referred for clinically indicated echocardiography who demonstrate stenosis, regurgitation, dehiscence.
Mitral regurgitation	Blood Draw	Echocardiographic and Doppler evaluation revealing mitral regurgitation with data adequate to calculate regurgitant volume
Mitral valve replacement	Blood Draw	Mechanical or biological mitral valve replacement
Hypertrophic cardiomyopathy	Blood Draw	Patients with known hypertrophic cardiomyopathy who are referred for clinically indicated echocardiography
Aortic Stenosis	Blood Draw	Restricted aortic valve motion and a peak Doppler aortic velocity \> 2.5 m/sec blood draw
Aortic valve replacement	Blood Draw	Mechanical or biological aortic valve replacement

Primary Outcome Measures

Name	Time	Method
Correlation of Von Willebrand Multimer ratio to cardiac lesion severity	2 years	To accomplish the specific aims, the investigators propose to collect clinical and echocardiographic data, and blood samples for von Willebrand Factor antigen and activity, von Willebrand Factor multimers, and BNP in patients with aortic stenosis, or aortic or mitral valve prosthesis, mitral regurgitation, hypertrophic cardiomyopathy, aortic regurgitation, and tricuspid regurgitation associated with pacemaker or defibrillator.

Secondary Outcome Measures

Name	Time	Method
Correlation of other VWF activity measures with cardiac lesion severity.	2 years	Comprehensively analyze the ability of VWF indices to discriminate severe from non-severe valvular disease, prosthetic valve dysfunction, and describe the prevalence of VWF abnormalities in this wide range of cardiac lesions associated with intravascular turbulence.