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

  • Study type:

    Observational What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Jacksonville, Florida: 09-006757
    • Rochester, Minnesota: 09-006757
  • NCT ID:

    NCT01334801
  • Sponsor Protocol Number:

    09-006757

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Joseph Blackshear, M.D.

Contact us for the latest status

Marcia Dubin CCRP

(904)953-8268

Dubin.Marcia@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Blackshear, M.D.

Contact us for the latest status

Marcia Dubin CCRP

(904)953-8268

Dubin.Marcia@mayo.edu