Jacksonville, Florida 32224


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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

09-006757


NCT ID:

NCT01334801


Secondary ID:


Study Acronym:

BASS


Brief Title:

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


Official Title:

Biomarkers in Aortic Stenosis, Hypertrophic Cardiomyopathy, Mitral Regurgitation, Aortic Regurgitation, Prosthetic Heart Valve Dysfunction, and Tricuspid Regurgitation From Pacemaker Leads Study


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

11


Total Enrollment:

400


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Joseph L Blackshear, M.D.
Principal Investigator
Mayo Clinic
Primary Contact:Marcia F Dubin
904-953-8268
dubin.marcia@mayo.edu

Study Dates

Start Date:July 2010
Completion Date:December 31, 2025
Completion Type:Anticipated
Primary Completion Date:December 31, 2025
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 19, 2019
First Received Date:April 12, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Correlation of Von Willebrand Multimer ratio to cardiac lesion severity
Time Frame:2 years
Safety Issues:False
Description: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 aort
Outcome Type:Secondary Outcome
Measure:Correlation of other VWF activity measures with cardiac lesion severity.
Time Frame:2 years
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Procedure
Name:Blood Draw
Description:Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests: BNP (Brain Natriuretic Peptide) (PFA) Platelet Function Analyzer 100 von Willebrand Factor (vWF) antigen (vWF) multimers (vWF) *activity by latex aggregation Plasma stored for development of new testing approaches
Arm Name:Aortic Stenosis

Study Arms

Study Arm Type:Other
Arm Name:Renal dialysis patients
Description:Patients on hemodialysis, peritoneal dialysis, or chronic kidney disease with dialysis fistula to be created.
Study Arm Type:Other
Arm Name:Left ventricular assist device patients
Description:Patients with previously implanted LVAD
Study Arm Type:Other
Arm Name:Normal controls
Description:Patients with no heart murmur or history of valve replacement, stenosis, regurgitation, or hypertrophic cardiomyopathy
Study Arm Type:Other
Arm Name:Prosthetic valve dysfunction
Description:Patients with prior heart valve replacement or repair referred for clinically indicated echocardiography who demonstrate stenosis, regurgitation, dehiscence.
Study Arm Type:Other
Arm Name: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
Study Arm Type:Other
Arm Name:Hypertrophic cardiomyopathy
Description:Patients with known hypertrophic cardiomyopathy who are referred for clinically indicated echocardiography
Study Arm Type:Other
Arm Name:Mitral valve replacement
Description:Mechanical or biological mitral valve replacement
Study Arm Type:Other
Arm Name:Mitral regurgitation
Description:Echocardiographic and Doppler evaluation revealing mitral regurgitation with data adequate to calculate regurgitant volume
Study Arm Type:Other
Arm Name:Aortic valve replacement
Description:Mechanical or biological aortic valve replacement
Study Arm Type:Other
Arm Name:Aortic regurgitation
Description:Echocardiographic and Doppler evaluation revealing aortic regurgitation with data adequate to calculate regurgitant volume
Study Arm Type:Other
Arm Name:Aortic Stenosis
Description:Restricted aortic valve motion and a peak Doppler aortic velocity > 2.5 m/sec blood draw

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic

Samples and Retentions

Sample Retention:Samples Without DNA
Description: whole blood
Study Population: Cardiology, referred for clinically-indicated echocardiograms
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
Citation:1. Error occurred: cannot get document summary PMID: 2924196253
PMID:2924196253

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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