Investigators plan evaluate whether PCSK9 inhibitors, a medication that can lower lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis, through a randomized controlled trial.
Aortic valve disease is the most common form of heart valve disease and is a major burden to society. Aortic valve disease is also expected to become more prevalent with the aging. Among aortic diseases, 'aortic stenosis (AS)', which is a narrowing of the aortic valve, and leads to symptoms of heart failure and sometimes death. For treatment of AS, the valve in replaced in a surgical to percutaneous method. Regardless of the method, valve replacement has its potential costs and complications that is an important issue that needs to be solved. Therefore, controlling the progression of AS and increasing the efficacy of medical therapy before valvular replacement is needed, is an important medico-social problem. Regarding the pathophysiology of AS, an elevation of lipoprotein(a) and dyslipidemia have been reported to be associated with the progression of cardiovascular calcification. PCSK9 inhibitors, which is a medication that can control both lipoprotein(a) and dyslipidemia may be a effective medication to control the progression of AS. Therefore, investigators will perform a randomized control trial, to compare the effect of PCSK9 inhibitors vs. placebo in its influence to AS progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
Patients will receive PCSK9 inhibitor by a biweekly injection
Patients will receive Placebo by a biweekly injection
Seoul National University Hospital
Seoul, South Korea
Progression of the Calcium score measured by cardiac CT (Agatston score) and by NaF PET
Calcium score progression in the PCSK9 inhibitor group and placebo group
Time frame: 2 years
Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs
Time frame: 2 years
Mean change in Lp(a) levels between treatment arms
Lp(a) levels will be measured in blood chemistry
Time frame: 2 years
Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level
Lipid panels will be measured in blood chemistry
Time frame: 2 years
Aortic valve area measured by echocardiography
Time frame: 2 years
Aortic valve peak velocity measured by echocardiography
Time frame: 2 years
Any death event
Time frame: 2 years
Any cardiac death event
Time frame: 2 years
Any myocardial infarction event
Time frame: 2 years
Any revascularization for coronary artery disease
Time frame: 2 years
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