Biomarkers in Aortic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic Stenosis

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

Blood Draw

Intervention Type PROCEDURE

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

Aortic regurgitation

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

Blood Draw

Intervention Type PROCEDURE

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

Aortic valve replacement

Mechanical or biological aortic valve replacement

Blood Draw

Intervention Type PROCEDURE

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

Mitral regurgitation

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

Blood Draw

Intervention Type PROCEDURE

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

Mitral valve replacement

Mechanical or biological mitral valve replacement

Blood Draw

Intervention Type PROCEDURE

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

Hypertrophic cardiomyopathy

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

Blood Draw

Intervention Type PROCEDURE

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

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

Blood Draw

Intervention Type PROCEDURE

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

Prosthetic valve dysfunction

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

Blood Draw

Intervention Type PROCEDURE

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

Normal controls

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

No interventions assigned to this group

Left ventricular assist device patients

Patients with previously implanted LVAD

No interventions assigned to this group

Renal dialysis patients

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

No interventions assigned to this group

Interventions

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Blood 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes