ACAV: EFFICACY AND SAFETY OF ALIROCUMAB TO PREVENT EARLY CARDIAC ALLOGRAFT VASCULOPATHY IN RECENT HEART TRANSPLANT RECIPIENTS
This study, called ACAV, is investigating a medicine called Alirocumab. It's for people who have recently had a heart transplant. The main goal is to see if Alirocumab can help stop a problem called cardiac allograft vasculopathy, which is when the arteries in the new heart start to thicken and narrow soon after the transplant. This narrowing can be a serious issue, so researchers want to find ways to prevent it. Participants will either receive Alirocumab or a placebo (a dummy drug that looks like Alirocumab but has no active ingredient). The study will carefully measure different types of cholesterol and fats in the blood at several points during the treatment. This will help doctors understand if Alirocumab is effective and safe in preventing this complication after a heart transplant.
At a glance
What is this study about?
When someone has a heart transplant, a common and serious problem that can happen is called cardiac allograft vasculopathy. This is a big name for a condition where the blood vessels (arteries) within the new, transplanted heart start to get thicker and narrower over time. This process can reduce the blood flow to the heart, which is very dangerous and can lead to serious health issues.
This study, called ACAV, is looking at a new medicine named Alirocumab. It's a 'Phase IV' study, which means the drug is already approved for other uses, but doctors are now studying it further for this specific problem in heart transplant patients. They want to find out if Alirocumab can effectively prevent these arteries from narrowing and thickening, especially in the early period after a heart transplant when this complication often begins.
To do this, some patients will receive Alirocumab, while others will receive a 'placebo.' A placebo looks exactly like the real medicine but contains no active drug. This is a standard way to see if the actual medicine is truly working or if any benefits are due to other factors. Doctors will then closely monitor and compare different types of fats and cholesterol in the blood of both groups at various times during the study. They will also use special scans to look at the thickness of the artery walls and how open the vessels are, to see if Alirocumab makes a positive difference.
Key takeaways
- This study investigates a drug to prevent artery narrowing in transplanted hearts.
- It aims to make heart transplants last longer and be safer.
- You might receive the active drug or a dummy drug (placebo).
- Participation involves regular blood tests and heart scans.
- The study helps develop better treatment for heart transplant patients.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults who have recently undergone a heart transplant. You must be at least 18 years old to take part; there's no upper age limit mentioned.
Both men and women are welcome to participate in this research.
The specific details of the individual's health after transplant, other medications they are taking, and general health status will be carefully checked to make sure it's safe and appropriate for them to join the study. This helps ensure the study results are clear and reliable.
- Have I recently had a heart transplant?
- Am I at least 18 years old?
- Am I comfortable with regular blood tests and heart scans?
- Am I able to attend several study visits?
- Am I willing to potentially receive a placebo?
- Do I understand that this is a research study and not guaranteed treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given either the study drug, Alirocumab, or a placebo (a dummy drug). You won't know which one you're receiving, nor will your study doctors. You will have several visits where blood samples will be taken to measure different types of fats and cholesterol. These measurements will happen at Treatment visits 2, 3, 4, 5, and 6. At the beginning of the study and at Treatment visit 6, special scans will be done to look closely at your heart's arteries. There will also be a follow-up visit after Treatment visit 6. The total duration of your active involvement in the study will involve multiple visits over a period up to and including Visit 7.
Potential risks and benefits
Locations (1)
- —Czechia
Common questions
What is cardiac allograft vasculopathy?
It's a problem where the blood vessels in a new, transplanted heart start to thicken and narrow, which can reduce blood flow to the heart.
What is Alirocumab?
Alirocumab is a medicine that doctors are studying to see if it can help prevent the blood vessels in transplanted hearts from narrowing.
What is a placebo?
A placebo is a 'dummy' drug that looks like the real medicine but doesn't contain any active ingredients. It helps doctors see if the real medicine is actually working.
Will I know if I'm getting the real drug or the placebo?
Neither you nor your study doctors will know whether you are receiving Alirocumab or the placebo. This is a common practice in clinical trials.
What will I have to do if I join the study?
You'll have several visits for blood tests and special heart scans, and you'll take either the study drug or the placebo.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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