Effect of Bisoprolol on Progression of Aortic Stenosis (BLAST)
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|ClinicalTrials.gov Identifier: NCT01579058|
Recruitment Status : Terminated (The sponsor discontinued to support the study.)
First Posted : April 17, 2012
Last Update Posted : May 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis||Drug: bisoprolol Drug: placebo||Phase 4|
Aortic stenosis (AS) is a gradually progressive disease, characterized by an increase in calcium deposition leading to progressive narrowing of the aortic valve (AV). There are currently no effective medical treatment to halt the disease process and surgical valve replacement remains the only proven therapy when the valve becomes severely stenotic. AS is mediated by a chronic inflammatory disease process, very similar to that seen in atherosclerosis, but lipid-lowering therapy did not slow the progression of AS in the SALTIRE, SEAS, or ASTRONOMER trials. It is possible that these trials may have targeted patients in whom disease was too advanced for lipid-lowering therapy to be effective, or in whom atherosclerotic mechanism was not the central pathogenic process in AS. Because identifying and treating patients in earlier stages of AS would not be cost-effective, it seems more logical to explore alternative pharmacological approaches.
AS has been thought to be a degenerative process basically induced by long-lasting mechanical stress, and hemodynamic factors such as shear forces, acceleration of blood flow, hypertension and rapid heart rate might contribute to progression of AS. Peak aortic jet velocity is known to be associated with clinical outcomes in mild and moderate AS, and our previous study showed that rate of progression was significantly associated with baseline aortic jet velocity in mild AS. Because beta-blocker therapy would decrease aortic jet velocity and heart rate, it might decrease hemodynamic stress and eventually slow down the degenerative process in patients whose disease is not too advanced for therapy to be effective. In a retrospective, observational study, beta-blocker therapy was associated with a favorable clinical outcome in AS.
The investigators hypothesized that bisoprolol, a new generation beta-blocker, would decrease the rate of progression of AS by modifying hemodynamic factors favorably in patients with mild to moderate AS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Trial of Beta-blocker Therapy in Aortic Stenosis|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
U.S. FDA Resources
Active Comparator: bisoprolol
bisoprolol 5mg qd
bisoprolol 5mg qd for 4 years
Other Name: Concor
Placebo Comparator: placebo
placebo for 4 years
- Change in peak aortic jet velocity from baseline to 4 years follow-up [ Time Frame: 4 years ]Change in peak aortic jet velocity from baseline to 4 years follow-up. For each patient, the change in peak aortic jet velocity is calculated as (peak aortic jet velocity at 4 year follow-up) − (peak aortic jet velocity at baseline) on Doppler echocardiography.
- Change in mean pressure gradient across aortic valve [ Time Frame: 4 years ]Change in mean pressure gradient across aortic valve from baseline to 4 years follow-up
- Change in aortic valve area [ Time Frame: 4 years ]Change in aortic valve area from baseline to 4 years follow-up
- Change in BNP levels [ Time Frame: 4 years ]Change in BNP levels from baseline to 4 years follow-up
- Change in E/E' ratio [ Time Frame: 4 years ]Change in the ratio of E velocity (early mitral inflow velocity) to E' velocity (early mitral annular velocity) from baseline to 4 years follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579058
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Duk-Hyun Kang, M.D.||Asan Medical Center|