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Study on Icosapent Ethyl for Slowing Aortic Valve Stenosis Progression in Patients with Aortic Valve Stenosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called icosapent ethyl on a condition known as aortic valve stenosis. Aortic valve stenosis is a heart condition where the valve between the heart and the main blood vessel to the body becomes narrowed, making it harder for the heart to pump blood. The medication being tested, icosapent ethyl, is provided in the form of soft capsules known as Vazkepa 998 mg soft capsules. The purpose of the study is to see if icosapent ethyl can slow down the progression of calcification, which is the buildup of calcium, in the aortic valve.

Participants in the study will take the medication orally, which means it is swallowed. The study will last for a period of 24 months, during which time the effects of the medication on the aortic valve will be monitored. This includes looking at changes in the amount of calcium in the valve, as well as other factors like the speed of blood flow through the valve and the size of the valve opening. The study will also examine changes in the volume of plaque, which is a buildup of substances in the arteries, in the heart's blood vessels.

The trial aims to provide valuable information on whether icosapent ethyl can help manage aortic valve stenosis by slowing down the calcification process. This could potentially lead to new treatment options for individuals with this heart condition. Participants will be monitored throughout the study to ensure their safety and to gather data on the medication's effectiveness.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting the inclusion criteria: age over 50 years and mild to moderate aortic valve stenosis.
No specific exclusion criteria are listed.
Step 2
Medication administration
Receive Vazkepa 998 mg soft capsules containing icosapent ethyl.
Take the medication orally as directed by the study protocol.
Step 3
Monitoring and assessments
Undergo regular assessments to monitor the progression of aortic valve calcification.
Primary endpoint: change in aortic valve calcium at 24 months.
Secondary endpoints include changes in peak aortic jet velocity, calculated aortic valve area, and coronary plaque volume.
Step 4
Completion of the study
The study is expected to conclude by June 30, 2026.
Final assessments will determine the effect of icosapent ethyl on the progression of aortic valve stenosis.

Who can join the trial?

4 criteria

Must be older than 50 years.
Must have **mild to moderate aortic valve stenosis**. This means the valve in the heart that controls blood flow from the heart to the body is narrowed, but not severely.
Both men and women can participate.
Participants should not be from vulnerable populations, meaning they should be able to make decisions for themselves and not be in a situation where they are easily influenced or at risk.

Who cannot join the trial?

9 criteria

Patients with any other heart condition besides aortic valve stenosis cannot participate. Aortic valve stenosis is a condition where the valve between the heart and the main blood vessel to the body becomes narrow.
Patients who have had heart surgery in the past 6 months are not eligible.
Individuals with severe kidney disease cannot take part in the study. Severe kidney disease means the kidneys are not working well enough to clean the blood properly.
Patients who are currently participating in another clinical trial are excluded.
Women who are pregnant or breastfeeding cannot join the study.
Patients with a history of severe allergic reactions to fish or shellfish are not allowed to participate.
Individuals with uncontrolled high blood pressure are excluded. Uncontrolled high blood pressure means the blood pressure is too high and not being managed well with treatment.
Patients with a history of alcohol or drug abuse in the past year cannot take part in the study.
Individuals with any other serious medical condition that might interfere with the study are not eligible.

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Icosapent Ethyl is being studied to see if it can slow down the progression of aortic valve calcification. This medication is a type of omega-3 fatty acid, which is often used to help lower certain types of fat in the blood. In this trial, researchers are investigating whether it can also help with heart valve issues by reducing the buildup of calcium in the aortic valve, which can lead to a condition known as aortic valve stenosis.

Icosapent Ethyl

What is already known about the treatment

Icosapent Ethyl – This medication is administered orally in the form of capsules. It is currently being studied in clinical trials for its potential to slow down the progression of aortic valve stenosis, a condition where the heart's aortic valve narrows. Icosapent ethyl is primarily used to reduce cardiovascular risk in patients with high triglyceride levels. It works by influencing lipid metabolism at the molecular level, helping to reduce inflammation and plaque formation in blood vessels. It is classified as an omega-3 fatty acid derivative.

Investigated diseases

Aortic valve stenosis – Aortic valve stenosis is a condition where the valve between the heart's left ventricle and the aorta becomes narrowed. This narrowing restricts blood flow from the heart to the rest of the body, causing the heart to work harder to pump blood. Over time, the increased workload can lead to thickening of the heart muscle and reduced heart function. As the condition progresses, symptoms such as chest pain, fatigue, and shortness of breath may develop. The severity of symptoms often correlates with the degree of valve narrowing. In advanced stages, the heart may struggle to maintain adequate blood flow, leading to further complications.