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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCSK9 inhibitor | Active Comparator | Patients will receive bi-weekly PCSK9 inhibitor . |
|
| Placebo | Placebo Comparator | Patients will receive bi-weekly placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCSK9 Inhibitor [EPC] | Drug | Patients will receive PCSK9 inhibitor by a biweekly injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of inhibition in calcium score progression (Agatston score) by the presence of Lp(a) SNPs | 2 years | |
| Mean change in Lp(a) levels between treatment arms | Lp(a) levels will be measured in blood chemistry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo-Soo Kim, MD, PhD | Contact | +82-2- 2072-2226 | hyosoo@snu.ac.kr | |
| Jeehoon Kang, MD | Contact | +82-10-2416-2406 | medikang@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C075010 | erucylphosphocholine |
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Prospective, Double blind, Multi-center, Randomized clinical trial
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| Placebos | Drug | Patients will receive Placebo by a biweekly injection |
|
| 2 years |
| Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level | Lipid panels will be measured in blood chemistry | 2 years |
| Aortic valve area measured by echocardiography | 2 years |
| Aortic valve peak velocity measured by echocardiography | 2 years |
| Any death event | 2 years |
| Any cardiac death event | 2 years |
| Any myocardial infarction event | 2 years |
| Any revascularization for coronary artery disease | 2 years |
| D014694 |
| Ventricular Outflow Obstruction |