CompletedNot ApplicableObservational

NLRP3 and SASP in Vazkepa therapy in patients with heart disease with or without type 2 diabetes

Vazkepa is a medicine that helps lower blood fats called triglycerides. We know it can reduce the risk of heart attacks and strokes in people with heart disease, with or without type 2 diabetes. However, we don't fully understand how it does this, beyond just lowering fats. This study aims to find out if Vazkepa helps calm down aggressive immune cells in the body, which can cause harmful inflammation in people with heart disease. By understanding this, we hope to learn more about how Vazkepa works and identify more people who could benefit from it. Participants will give blood samples over six months.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Lincoln

Enrolment target

Start

26 Apr 2024

Estimated completion

30 Apr 2026

Atherosclerotic cardiovascular disease with or without type 2 diabetes mellitus

What is this study about?

You might have heard of Vazkepa, a medicine that's often prescribed to help lower a type of fat in your blood called triglycerides. If you have heart disease, with or without type 2 diabetes, you might know that Vazkepa has been shown to reduce serious problems like heart attacks and strokes. However, scientists don't quite understand all the ways it works, as its benefits go beyond just lowering fat levels.

When someone has heart disease, their body's immune cells can sometimes become a bit overactive, leading to inflammation. This kind of inflammation is linked to worse outcomes in heart disease. This study wants to find out if Vazkepa can help these immune cells behave more calmly, which could reduce this harmful inflammation. We think this might be a key reason why Vazkepa is so effective in preventing heart attacks and strokes.

By carefully studying how Vazkepa affects these immune cells, we hope to gain a much clearer picture of its full benefits. This understanding could help more people with heart disease, and might even lead to new and better ways to treat heart conditions in the future.

Key takeaways

This study explores how Vazkepa, a heart medicine, works beyond just lowering fats.
It investigates if Vazkepa can reduce harmful inflammation linked to heart disease.
Results could help identify more patients who would benefit from Vazkepa.
Participation involves blood tests and regular check-ups with a heart specialist.
The study helps improve our understanding of heart disease treatments.
You will be reimbursed for study visits outside of your normal care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old. You should have heart disease, and you might also have type 2 diabetes. It's important that you are already taking statin medication, but your triglyceride levels (a type of fat in your blood) are still a bit high.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you have severe kidney or liver problems. If you've recently had a heart attack, surgery, or a serious infection in the last three months, you wouldn't be able to take part. Also, if you have certain active inflammatory conditions like cancer or an autoimmune disease, this study might not be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Do you have heart disease (with or without type 2 diabetes)?
Are you currently taking statins, but your blood triglyceride levels are still high?
Are you eligible for Vazkepa under current guidelines?
Are you not pregnant or breastfeeding?
Have you not had a heart attack, surgery, or severe infection in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be giving blood samples over a six-month period. You'll be randomly put into one of two groups: either you'll start taking Vazkepa at the very beginning of the study, or you'll start taking Vazkepa three months into the study. The research team will use these blood samples to look at your immune cells and how they respond to Vazkepa. They will also check your general health, which is standard practice when starting this type of medicine. You will have regular appointments with a heart specialist, both when you start and after three and six months, where you can discuss any health concerns.

Potential risks and benefits

Taking part in this study could help us better understand how Vazkepa works to protect your heart, which could lead to better treatments for heart disease in the future. You'll also get extra check-ups with a heart specialist, which means more opportunities to discuss your health. Vazkepa is a medicine that's already widely used and generally well-tolerated with few side effects. The main risk involved is the discomfort of having blood samples taken, which is done by experienced staff to make it as comfortable as possible. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (2)

Lincoln County Hospital
Approximate
Lincoln, England
University of Lincoln
Approximate
Lincoln, England

Common questions

What is Vazkepa?

Vazkepa is a medicine that helps lower a type of fat in your blood called triglycerides and has been shown to reduce the risk of heart attacks and strokes.

Will I have to pay to be in the study?

No, you will be paid back for any travel or time spent on study visits that are extra to your usual care.

What is the main goal of this study?

The study aims to understand *how* Vazkepa works in the body to reduce heart problems, especially by looking at its effect on inflammation.

How long will the study last for me?

If you take part, the study will involve giving blood samples over a period of six months.

Can I stop participating if I change my mind?

Yes, you can choose to stop participating at any time without it affecting your medical care.

How to find out more

Kelvin Lee

kelvin.lee@nhs.net +44 (0)1522 512512 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.