Aortic Stenosis, Aortic Valve Insufficiency, Disorder of Prosthetic Cardiac Valve, Hypertrophic Cardiomyopathy, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency
Conditions
Keywords
aortic stenosis, von Willebrand factor, mitral valve replacement, aortic valve replacement, prosthetic valve dysfunction, brain natriuretic peptide, mitral valve regurgitation, aortic valve regurgitation, hypertrophic cardiomyopathy, tricuspid insufficiency
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.
Interventions
PROCEDUREBlood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests: 1. BNP (Brain Natriuretic Peptide) 2. (PFA) Platelet Function Analyzer 100 3. von Willebrand Factor (vWF) antigen 4. (vWF) multimers 5. (vWF) \*activity by latex aggregation 6. Plasma stored for development of new testing approaches
Sponsors
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed