Take a new cholesterol-lowering medication to slow heart valve disease progression

Recruiting

What is this trial?

This trial is testing whether PCSK9 inhibitors — a newer class of cholesterol-lowering medications — can slow or prevent the worsening of calcific aortic valve stenosis (a condition where the heart's aortic valve becomes stiff and narrowed due to calcium buildup). Half the participants will take this medication on top of their regular statin therapy, while the other half will continue statins alone. The study will track how well each approach slows the disease over 2 years.

Currently, there are no proven medications that can slow or prevent calcific aortic valve stenosis — surgery to replace the valve is the only option. Early studies suggest that this medication might lower cholesterol more effectively than statins alone and may help reduce the risk of valve disease, so researchers want to test whether it actually works in patients with this condition.

Do you qualify?

You likely qualify if…

you are 18 years of age or older
you have been diagnosed with mild, moderate, or asymptomatic severe aortic valve stenosis confirmed by heart ultrasound
you have been taking a statin medication at a stable dose for at least 4 weeks
you have elevated cholesterol levels (LDL-C) and one major or three minor cardiovascular risk factors such as diabetes, previous heart attack, smoking, high blood pressure, or family history of heart disease
you are able and willing to commit to taking study medications for 24 months

You likely don't qualify if…

you have previously taken PCSK9 inhibitors
you have severe liver disease, severe kidney disease, or a history of stroke or brain bleeding
you have uncontrolled heart arrhythmias, severe heart failure, or a very low ejection fraction (below 30%)
you have a pacemaker or defibrillator implanted in your chest
you are pregnant, planning to become pregnant, or not using reliable contraception

What participation looks like

If you enroll, you will be randomly assigned to either take the new medication (injected under the skin every two weeks) plus your regular statin, or to continue with statins alone. You will visit the clinic at months 3, 6, 9, 12, 15, 18, 21, and 24, where you'll have heart ultrasounds, blood tests, and possibly CT scans of your heart. You'll also complete questionnaires about your quality of life and symptoms. The study lasts at least 2 years.

Testing a New Cholesterol Drug for Heart Valve Disease

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)