Clinical Trial: PCSK9 Inhibitors in the Progression of Aortic Stenosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Proprotein Convertase Subtilisin Kexin Type 9 Inhibitor in Aortic Stenosis

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Progression of the Calcium score measured by cardiac CT (Agatston score) and by NaF PET [ Time Frame: 2 years ]

Calcium score progression in the PCSK9 inhibitor group and placebo group


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 2 years ]
    Lp(a) levels will be measured in blood chemistry
  • Mean change in lipid panel (LDL, HDL, TG, Cholesterol) level [ Time Frame: 2 years ]
    Lipid panels will be measured in blood chemistry
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: January 23, 2017
Date Started: June 1, 2017
Date Completion: January 1, 2020
Last Updated: February 8, 2017
Last Verified: February 2017