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

NCT01334801 | Completed

• 1 other identifier: 09-006757
• Study Type: observational
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Correlation of Von Willebrand Multimer ratio to cardiac lesion severity

  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.

  2 years

Secondary Outcomes (1)

• Correlation of other VWF activity measures with cardiac lesion severity.

  2 years

Study Arms (11)

Aortic Stenosis

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

Procedure: Blood Draw

Aortic regurgitation

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

Procedure: Blood Draw

Aortic valve replacement

Mechanical or biological aortic valve replacement

Procedure: Blood Draw

Mitral regurgitation

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

Procedure: Blood Draw

Mitral valve replacement

Mechanical or biological mitral valve replacement

Procedure: Blood Draw

Hypertrophic cardiomyopathy

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

Procedure: 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

Prosthetic valve dysfunction

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

Procedure: Blood Draw

Normal controls

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

Left ventricular assist device patients

Patients with previously implanted LVAD

Renal dialysis patients

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

Interventions

Blood Draw 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 Stenosis; Aortic regurgitation; Aortic valve replacement; Hypertrophic cardiomyopathy; Mitral regurgitation; Mitral valve replacement; Prosthetic valve dysfunction; Severe TR with pacemaker / ICD lead

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiology, referred for clinically-indicated echocardiograms

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• Blackshear JL, Stark ME, Agnew RC, Moussa ID, Safford RE, Shapiro BP, Waldo OA, Chen D. Remission of recurrent gastrointestinal bleeding after septal reduction therapy in patients with hypertrophic obstructive cardiomyopathy-associated acquired von Willebrand syndrome. J Thromb Haemost. 2015 Feb;13(2):191-6. doi: 10.1111/jth.12780. Epub 2014 Dec 12.

  PMID: 25387993 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Cardiomyopathy, Hypertrophic; Tricuspid Valve Insufficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cardiomyopathies; Aortic Stenosis, Subvalvular

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Joseph L Blackshear, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 13, 2011
• Study Start: July 1, 2010
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

US (1)