Aortic stenosis, dyslipidemia Aortic stenosis, aortic valve, dyslipidemia, hypercholesterolemia, LDL cholesterol
Conditions
Interventions
Control treatment group (or group A)
:Standard treatment based on the 2022 edition of the Guidelines for Prevention of Atherosclerotic Diseases
Test treatment group (or group B)
:Statin plus evolocum
Sponsors
Hibi Kiyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women aged 18 years or older at the time of enrollment. (2) Patients diagnosed with moderate aortic valve stenosis. (3) Patients diagnosed with dyslipidemia. (4) Patients who provide written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Surgery for aortic stenosis (surgical aortic valve surgery or transcatheter aortic valve surgery) is planned. (2) History of aortic valve surgery (surgical aortic valve surgery or transcatheter aortic valve surgery). (3) Patients expected to have difficulty visiting the hospital. (4) Patients with advanced cancer or other conditions expected to have a prognosis of one year or less. (5) Hypersensitivity to evolocumab. (6) Patients with the following conditions considered to have reduced hepatic metabolic function (acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, jaundice). (7) Women who are pregnant or breastfeeding, may be pregnant, or wish to become pregnant during treatment. (8) Patients receiving medications containing cyclosporine, itraconazole, miconazole, posaconazole, glecaprevir, pibrentasvir, atazanavir, saquinavir mesilate, or cobicistat. (9) Patients with a history of treatment with evolocumab or inclisiran. (10) Other patients who are deemed inappropriate by a physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in maximum aortic valve pressure gradient after 12 months as assessed by transthoracic echocardiography | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change in mean aortic valve pressure difference after 12 months (2) Change in aortic valve area after 12 months, change in aortic valve area corrected for body surface area (3) Change in maximum aortic valve pressure difference after 24 months (4) Change in mean aortic valve pressure difference after 24 months (5) Change in aortic valve area after 24 months, change in aortic valve area corrected for body surface area (6) Change in other items by echocardiography (left ventricular ejection fraction, E/A, E/E', left ventricular end-diastolic dimension, stroke volume, stroke volume index, velocity time integral of left ventricular outflow tract blood flowleft, left ventricular mass, left ventricular mass index, left atrial diameter, left atrial volume, left atrial volume index, GLS) (7) Change in aortic valve calcification score by CT, coronary artery calcification score by CT, and fat arround the heart by CT (8) Changes in blood test items (white blood count, red blood cell count, hematocrit, hemoglobin, platelets, total protein, serum albumin, total bilirubin, AST, ALT, LDH, ALP, GTP, CK, BUN, serum creatinine, eGFR, uric acid, Na, K, Cl, Ca, IP, CRP, random blood glucose, HbA1c, LDL-C, HDL-C, TG, Lp(a), BNP or NT-proBNP) (9) MACCE (total mortality, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure) (10) Aortic stenosis events (surgery for aortic stenosis, hospitalization for heart failure due to aortic stenosis, sudden cardiac death) (11) All cause death (12) Cardiovascular death (13) Nonfatal myocardial infarction (14) Nonfatal stroke (15) Hospitalization for heart failure | — |
Contacts
Public ContactMasaomi Gohbara
Yokohama City University Medical Center
Outcome results
None listed