Biomarkers in Aortic Stenosis - B.A.S.S. (BASS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aortic Stenosis Mitral Valve Replacement Aortic Valve Replacement Prosthetic Heart Valve Dysfunction Aortic Insufficiency Mitral Insufficiency Hypertrophic Cardiomyopathy Tricuspid Regurgitation With Pacemaker/Defibrillator Leads |
Procedure: Blood Draw Other: Blood draw |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | Biomarkers in Aortic Stenosis, Hypertrophic Cardiomyopathy, Mitral Regurgitation, Aortic Regurgitation, Prosthetic Heart Valve Dysfunction, and Tricuspid Regurgitation From Pacemaker Leads Study |
- Correlation of Von Willebrand Multimer ratio to cardiac lesion severity [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Correlation of other VWF activity measures with cardiac lesion severity. [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
whole blood
| Estimated Enrollment: | 280 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Aortic Stenosis
Restricted aortic valve motion and a peak Doppler aortic velocity > 2.5 m/sec
|
Procedure: Blood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
Blood draw
|
|
Aortic regurgitation
Echocardiographic and Doppler evaluation revealing aortic regurgitation with data adequate to calculate regurgitant volume
|
Procedure: Blood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
Blood draw
|
|
Aortic valve replacement
Mechanical or biological aortic valve replacement
|
Procedure: Blood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
Blood draw
|
|
Mitral regurgitation
Echocardiographic and Doppler evaluation revealing mitral regurgitation with data adequate to calculate regurgitant volume
|
Procedure: Blood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
Blood draw
|
|
Mitral valve replacement
Mechanical or biological mitral valve replacement
|
Procedure: Blood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
Blood draw
|
|
Hypertrophic cardiomyopathy
Patients with known hypertrophic cardiomyopathy who are referred for clinically indicated echocardiography
|
Procedure: Blood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
Blood draw
|
|
Severe TR with pacemaker / ICD lead
Patients referred for clinically indicated echocardiography who have severe tricuspid regurgitation associated with a pacemaker or defibrillator lead documented by echocardiography
|
Procedure: Blood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
Blood draw
|
|
Prosthetic valve dysfunction
Patients with prior heart valve replacement or repair referred for clinically indicated echocardiography who demonstrate stenosis, regurgitation, dehiscence.
|
Procedure: Blood Draw
Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
Blood draw
|
|
Normal controls
Patients with no heart murmur or history of valve replacement, stenosis, regurgitation, or hypertrophic cardiomyopathy
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Cardiology, referred for clinically-indicated echocardiograms
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
Contacts and Locations More Information
Publications:
| Responsible Party: | Joseph L. Blackshear, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01334801 History of Changes |
| Other Study ID Numbers: | 09-006757 |
| Study First Received: | April 12, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
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 |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Aortic Stenosis, Subvalvular Aortic Valve Insufficiency Cardiomyopathy, Hypertrophic Constriction, Pathologic Hypertrophy Mitral Valve Insufficiency Tricuspid Valve Insufficiency Cardiomyopathies Heart Valve Diseases |
Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Pathological Conditions, Anatomical Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013