effect of EVOlocumab on the progression of moderate Aortic Stenosis trial

JRCT ID: jRCTs031240618

Registered date:17/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Aortic stenosis, dyslipidemia
• Date of first enrollment: 25/02/2025
• Target sample size: 126
• Study type: Interventional

Intervention(s)

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 evolocumab 140 mg (every 2 weeks) for patients with statin tolerance, evolocumab 140 mg (every 2 weeks) for patients without statin tolerance. Other treatments were standard treatments based on the 2022 edition of the Guidelines for Prevention of Atherosclerotic Diseases.

Outcome(s)

• Primary Outcome: Change in maximum aortic valve pressure gradient after 12 months as assessed by transthoracic echocardiography

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hibi Kiyoshi