Biomarkers in Aortic Stenosis - B.A.S.S. (BASS)

This study has suspended participant recruitment.
(Awaiting IRB approval of protocol modification)
Sponsor:
Information provided by (Responsible Party):
Joseph L. Blackshear, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01334801
First received: April 12, 2011
Last updated: January 15, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:

  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
Other: Blood draw
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:

  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
Other: Blood draw
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:

  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
Other: Blood draw
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:

  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
Other: Blood draw
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:

  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
Other: Blood draw
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:

  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
Other: Blood draw
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:

  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
Other: Blood draw
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:

  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
Other: Blood draw
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
Study Population

Cardiology, referred for clinically-indicated echocardiograms

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334801

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Joseph L Blackshear, M.D. Mayo Clinic
  More Information

No publications provided

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
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Constriction, Pathologic
Hypertrophy
Mitral Valve Insufficiency
Tricuspid Valve Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014