Active not recruitingOBSERVATIONAL

Statin-Intolerance Registry

This study is called the Statin-Intolerance Registry. It's for people who have high cholesterol but find it difficult to take statin medication, often due to side effects. Statin intolerance is quite common but not fully understood, and it's important to prevent heart and blood vessel problems (like heart attacks or strokes). Researchers want to learn more about people who experience statin intolerance, including why it happens and how it affects their long-term health. The study will collect information over time to help doctors better understand and manage this condition in the future.

At a glance

Status

Active not recruiting

Sponsor

University of Leipzig

Enrolment target

1,000

Start

01 Aug 2021

Estimated completion

01 Aug 2026

Dyslipidemias

What is this study about?

This study, called the Statin-Intolerance Registry, is for individuals who have dyslipidemia (often called high cholesterol) and find that they can't take certain cholesterol-lowering medicines called statins. Statins are usually very effective at reducing the risk of heart disease and strokes, but some people experience side effects that make it hard for them to continue taking them. This is known as statin intolerance.

Researchers want to get a clearer picture of who these patients are, why they can't tolerate statins, and what happens to their health over time. By collecting information from a lot of people, the study hopes to improve our understanding of statin intolerance, which could eventually lead to better ways to help patients manage their cholesterol and protect their hearts, even if they can't take statins.

It's important to know that this is an 'observational' study. This means you won't be given any new medicines or treatments as part of the study itself. Your doctor will continue to treat you as they normally would, based on what's best for your health. The study will simply collect information about your health and treatments as they happen in real life.

Key takeaways

This study is for adults with high cholesterol who struggle to take statins.
It aims to understand statin intolerance better and improve patient care.
You won't get new medicines; your treatment stays the same.
Participation involves sharing health info and yearly follow-up visits.
Your involvement helps advance knowledge for others with statin intolerance.
You can stop participating at any time without penalty.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The main requirement is that you have high cholesterol and have experienced statin intolerance. This means you've tried at least two different statin medications, or tried to increase the dose of one, but couldn't tolerate them. Your symptoms should also get better or disappear when you reduce the statin dose or stop taking it completely.

You also need to be able to understand the study information and be willing to give your written consent to take part. It's important that you're likely to be available for follow-up appointments over the next year.

There are a few reasons you wouldn't be able to join. For example, if you've recently taken part in another study involving new, experimental drugs in the last 30 days. Also, if you or a close family member works for the clinic running the study, you wouldn't be eligible.

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 18 years old or older?
Do you have high cholesterol (dyslipidemia)?
Have you tried at least two different statins, or tried increasing your statin dose, but couldn't tolerate them due to side effects that improved when you stopped or reduced the dose?
Are you able to provide written consent and attend yearly follow-up appointments for at least a year?
Have you avoided any experimental drug treatments in the last 30 days?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be asked to provide information about your health and medical history, especially regarding your cholesterol and statin experiences. This will happen when you first enrol in the study, likely through questionnaires.

After your initial visit, you'll have follow-up visits once a year. During these yearly check-ups, the study team will re-check some of your health information and record any new heart or blood vessel problems you might have experienced. The study won't change your current medical treatment; your doctor will continue to manage your care as usual. The researchers are simply observing and collecting information based on your routine medical care. The study aims to follow participants for at least one year.

Potential risks and benefits

A potential benefit of taking part in this study is contributing to a better understanding of statin intolerance. This knowledge could help many people in the future who struggle to take statins. Since this is an observational study, it does not involve new treatments, so there are no direct medical risks from participating. Your medical care will continue as normal. The main 'risk' is the time commitment for filling out questionnaires and attending follow-up visits. You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

Uniklinik Leipzig
Verified postcode
Leipzig, Germany

Common questions

What is 'statin intolerance'?

It means you have side effects from statin medicines that make it hard to take them, even after trying different types or doses. These side effects often improve or go away when you stop or reduce the statin.

Will this study give me new medicine?

No, this study is about observing your health and treatment you already receive. It won't involve giving you any new medicines or changing your current treatment plan.

How often will I need to visit?

You'll have an initial visit to provide your health history. After that, you'll have one follow-up visit each year for at least a year.

Why is this study important?

It helps doctors better understand why some people can't take statins. This knowledge can improve how we treat high cholesterol and prevent heart problems for people who are statin intolerant.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.