Clinical trial NCT01334801: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 378
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology, referred for clinically-indicated echocardiograms

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.

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 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

Primary outcomes:
measure: Correlation of Von Willebrand Multimer ratio to cardiac lesion severity
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of other VWF activity measures with cardiac lesion severity.
timeFrame: 2 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Joseph L Blackshear, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.