Aortic StenosisBASSNCT01334801
Biomarkers in Aortic Stenosis - B.A.S.S.
An observational study of Aortic Stenosis and Disorder of Prosthetic Cardiac Valve, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 378 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 31 Jan 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiology, referred for clinically-indicated echocardiograms
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers in Aortic Stenosis, Hypertrophic Cardiomyopathy, Mitral Regurgitation, Aortic Regurgitation, Prosthetic Heart Valve Dysfunction, and Tricuspid Regurgitation From Pacemaker Leads 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.
Read the 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.
- Conditions
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Hypertrophic Cardiomyopathy, Tricuspid Valve Insufficiency
- Being tested
- Blood Draw
- 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
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Cardiomyopathy, Hypertrophic, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Aortic Stenosis | Restricted aortic valve motion and a peak Doppler aortic velocity > 2.5 m/sec blood draw Receives: Procedure: Blood Draw | |
| Aortic regurgitation | Echocardiographic and Doppler evaluation revealing aortic regurgitation with data adequate to calculate regurgitant volume Receives: Procedure: Blood Draw | |
| Aortic valve replacement | Mechanical or biological aortic valve replacement Receives: Procedure: Blood Draw | |
| Mitral regurgitation | Echocardiographic and Doppler evaluation revealing mitral regurgitation with data adequate to calculate regurgitant volume Receives: Procedure: Blood Draw | |
| Mitral valve replacement | Mechanical or biological mitral valve replacement Receives: Procedure: Blood Draw | |
| Hypertrophic cardiomyopathy | Patients with known hypertrophic cardiomyopathy who are referred for clinically indicated echocardiography Receives: 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 Receives: Procedure: Blood Draw | |
| Prosthetic valve dysfunction | Patients with prior heart valve replacement or repair referred for clinically indicated echocardiography who demonstrate stenosis, regurgitation, dehiscence. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Correlation of other VWF activity measures with cardiac lesion severity.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startJul 2010
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 378 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph L Blackshear, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334801
- Sponsor's protocol ID
- 09-006757
- Acronym
- BASS
- Status last verified
- May 2022
- First submitted
- 12 Apr 2011
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25387993
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Aortic Stenosis, Hypertrophic Cardiomyopathy, Mitral Regurgitation, Aortic Regurgitation, Prosthetic Heart Valve Dysfunction, and Tricuspid Regurgitation From Pacemaker Leads Study
- ClinicalTrials.gov ID
- NCT01334801
- Acronym / sponsor ID
- BASS / 09-006757
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Aortic Stenosis | – | Procedure: Blood DrawRestricted aortic valve motion and a peak Doppler aortic velocity > 2.5 m/sec blood draw |
| Aortic regurgitation | – | Procedure: Blood DrawEchocardiographic and Doppler evaluation revealing aortic regurgitation with data adequate to calculate regurgitant volume |
| Aortic valve replacement | – | Procedure: Blood DrawMechanical or biological aortic valve replacement |
| Mitral regurgitation | – | Procedure: Blood DrawEchocardiographic and Doppler evaluation revealing mitral regurgitation with data adequate to calculate regurgitant volume |
| Mitral valve replacement | – | Procedure: Blood DrawMechanical or biological mitral valve replacement |
| Hypertrophic cardiomyopathy | – | Procedure: Blood DrawPatients with known hypertrophic cardiomyopathy who are referred for clinically indicated echocardiography |
| Severe TR with pacemaker / ICD lead | – | Procedure: Blood DrawPatients referred for clinically indicated echocardiography who have severe tricuspid regurgitation associated with a pacemaker or defibrillator lead documented by echocardiography |
| Prosthetic valve dysfunction | – | Procedure: Blood DrawPatients with prior heart valve replacement or repair referred for clinically indicated echocardiography who demonstrate stenosis, regurgitation, dehiscence. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology, referred for clinically-indicated echocardiograms
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Missing or inadequate echocardiographic data
- inability to give informed consent
- inability to provide a research blood sample
- hemoglobin less than 8
- severe valvular regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawTwo 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 | Procedure or surgery | Aortic Stenosis, Aortic regurgitation, Aortic valve replacement, Hypertrophic cardiomyopathy, Mitral regurgitation, Mitral valve replacement, Prosthetic valve dysfunction, Severe TR with pacemaker / ICD lead |
Primary outcome
Correlation of Von Willebrand Multimer ratio to cardiac lesion severity
Time frame: 2 years
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.
1 secondary outcome
Correlation of other VWF activity measures with cardiac lesion severity.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 25387993Blackshear 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph L Blackshear, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Disorder of Prosthetic Cardiac Valve, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Von Willebrand Multimer ratio to cardiac lesion severity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.