Biomarkers in Aortic Stenosis - B.A.S.S. (BASS)

Mayo Clinic

Status: Completed

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

Treatments: Procedure: Blood Draw

Study type: Observational

Funder types: Other

Identifiers

NCT01334801

09-006757

Details and patient eligibility

About

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.

Full 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.

Enrollment: 378 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

378 participants in 11 patient groups

Aortic Stenosis

Description:

Restricted aortic valve motion and a peak Doppler aortic velocity \> 2.5 m/sec blood draw

Treatment:

Procedure: Blood Draw

Aortic regurgitation

Description:

Echocardiographic and Doppler evaluation revealing aortic regurgitation with data adequate to calculate regurgitant volume

Treatment:

Procedure: Blood Draw

Aortic valve replacement

Description:

Mechanical or biological aortic valve replacement

Treatment:

Procedure: Blood Draw

Mitral regurgitation

Description:

Echocardiographic and Doppler evaluation revealing mitral regurgitation with data adequate to calculate regurgitant volume

Treatment:

Procedure: Blood Draw

Mitral valve replacement

Description:

Mechanical or biological mitral valve replacement

Treatment:

Procedure: Blood Draw

Hypertrophic cardiomyopathy

Description:

Patients with known hypertrophic cardiomyopathy who are referred for clinically indicated echocardiography

Treatment:

Procedure: Blood Draw

Severe TR with pacemaker / ICD lead

Description:

Patients referred for clinically indicated echocardiography who have severe tricuspid regurgitation associated with a pacemaker or defibrillator lead documented by echocardiography

Treatment:

Procedure: Blood Draw

Prosthetic valve dysfunction

Description:

Patients with prior heart valve replacement or repair referred for clinically indicated echocardiography who demonstrate stenosis, regurgitation, dehiscence.

Treatment:

Procedure: Blood Draw

Normal controls

Description:

Patients with no heart murmur or history of valve replacement, stenosis, regurgitation, or hypertrophic cardiomyopathy

Left ventricular assist device patients

Description:

Patients with previously implanted LVAD

Renal dialysis patients

Description:

Patients on hemodialysis, peritoneal dialysis, or chronic kidney disease with dialysis fistula to be created.