A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called PCSK9 inhibitor to see if it can help slow down the worsening of calcified aortic valve disease, specifically a condition known as aortic stenosis. The trial aims to find out not only if the drug can delay the progression of this heart condition but also if it is safe for patients to use. Researchers will also look at other factors, such as whether the drug can help prevent serious health issues and its effect on certain cholesterol levels in the blood.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with aortic stenosis through an ultrasound of the heart. They should also have high cholesterol that hasn’t responded well to the highest dose of cholesterol-lowering medications called statins. However, some people may not qualify, such as those who have certain severe health conditions, plan to have heart surgery soon, or have previously used PCSK9 inhibitors. If someone joins the trial, they can expect to receive the medication and participate in regular check-ups to monitor their health, helping researchers learn more about this treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily sign informed consent;
• • Age ≥18 years old, gender unlimited;
• • Patients with aortic stenosis diagnosed by echocardiography;
• • Combined with atherosclerotic cardiovascular disease or
• • hypercholesterolemia LDL-C≥4.9mmol/L;
• • The blood lipids were not up to standard after the maximum tolerated dose of statins;
• Exclusion Criteria:
• • Rheumatic aortic stenosis;
• • Previous use of PCSK9 inhibitors or allergy to PCSK9 inhibitors;
• • Left ventricular ejection fraction ≤35%;
• • Patients planned to undergo aortic valve replacement or TAVR in the near future;
• • Complicated with other severe valvular diseases;
• • Poor adherence to treatment and inability to take medication according to the trial protocol;
• • Pregnant and lactating women;
• • Combined with active malignant tumors, severe liver and kidney dysfunction and other life expectancy of less than 1 year;
• • Participants who are participating in other interventional clinical studies;
• • Patients who were judged by the investigator to be ineligible for participation in the trial