Study on Alirocumab for Preventing Heart Vessel Disease in Recent Heart Transplant Patients

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What is this study about?

This clinical trial is focused on studying a condition called cardiac allograft vasculopathy, which can occur in patients who have recently received a heart transplant. The study is investigating the use of a medication called alirocumab, which is given as a solution for injection. Alirocumab is being tested to see if it can help prevent this condition in heart transplant recipients. The trial also includes a comparison with a placebo product, which is a substance with no active medication.

The purpose of the study is to evaluate how effective alirocumab is in lowering levels of LDL-cholesterol, often referred to as “bad cholesterol,” in patients who have recently undergone heart transplantation. The study will also look at the impact of alirocumab on other parts of the lipid profile, such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), lipoprotein a (Lp[a]), and triglyceride (TG) levels. These are all different types of fats and proteins in the blood that can affect heart health.

Participants in the study will receive either alirocumab or a placebo, in addition to their standard lipid-lowering therapy with atorvastatin, a common cholesterol-lowering medication. The study will take place over a period of 12 months, starting from 1 month after the heart transplant. During this time, the effects of the treatment on cholesterol levels and other lipid parameters will be monitored at various intervals to assess the potential benefits of alirocumab in preventing cardiac allograft vasculopathy.

1 joining the study

Upon joining the study, you will be asked to provide written consent, confirming your willingness to participate and your understanding of the study procedures.

You must be a recent heart transplant recipient, aged 18 or older, and your surgery should have been performed 3-8 weeks before the baseline visit.

2 baseline visit

During the baseline visit, your initial health status will be assessed. This includes measuring your cholesterol levels and other health parameters.

You will begin taking atorvastatin 10 mg daily as part of your standard background lipid-lowering therapy.

3 treatment visits

You will attend several treatment visits, labeled as Treatment visit 1, 2, 3, 4, 5, and 6. These visits will occur over a period of 1 to 12 months after your heart transplantation.

At each visit, your cholesterol levels and other lipid profile parameters will be measured. This includes LDL-C (low-density lipoprotein cholesterol), HDL-C (high-density lipoprotein cholesterol), TC (total cholesterol), TG (triglycerides), ApoB (apolipoprotein B), ApoA1 (apolipoprotein A1), and Lp(a) (lipoprotein a).

4 medication administration

You will receive either alirocumab or a placebo as a solution for injection. This will be administered subcutaneously, which means it is injected under the skin.

The frequency and dosage of the injections will be determined by the study protocol and communicated to you by the study team.

5 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the changes in your cholesterol levels and other health parameters.

The study aims to assess the efficacy of alirocumab in lowering LDL-cholesterol and its impact on other lipid profile parameters.

Who Can Join the Study?

Must be a new heart transplant recipient who is 18 years or older.
Must be willing to participate in the study.
Must be able to understand the study procedures and follow them for the entire length of the study.
Must provide written informed consent, which means agreeing to participate after understanding the study details. This can also be given by a legal representative if needed.
Must have had heart transplantation surgery 3 to 8 weeks before the first study visit.

Who Cannot Join the Study?

Patients who have not received a heart transplant recently.
Patients who are not experiencing cardiac allograft vasculopathy (a condition affecting the blood vessels of the transplanted heart).
Patients who are not taking atorvastatin 10 mg daily as part of their standard treatment.
Patients who are outside the age range specified for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ijvnhzbtp Fdm Cprbxwcg Ahp Eqjavozliiig Mdfhjjje	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.06.2019

Trial locations

Investigated drugs:

Alirocumab

Alirocumab is a medication used in this clinical trial to help lower levels of LDL cholesterol, which is often referred to as “bad” cholesterol. This medication is being tested to see if it can help prevent a condition called cardiac allograft vasculopathy, which can occur in people who have recently had a heart transplant. The trial is looking at how well alirocumab works when used alongside another cholesterol-lowering medication called atorvastatin. The goal is to see if alirocumab can improve the overall cholesterol profile, including other types of cholesterol and fats in the blood, over a period of one year after the heart transplant.

Atorvastatin is a medication that is commonly used to lower cholesterol levels in the blood. In this clinical trial, it is part of the standard treatment given to patients who have recently received a heart transplant. Atorvastatin works by reducing the amount of cholesterol made by the liver, which helps to lower the risk of heart disease and other related conditions. The trial is using atorvastatin as a background therapy to see how well it works in combination with another medication, alirocumab, to improve cholesterol levels and prevent complications after a heart transplant.

Investigated diseases:

Heart transplant

Cardiac allograft vasculopathy – This disease occurs in individuals who have received a heart transplant. It involves the thickening and narrowing of the blood vessels in the transplanted heart. Over time, this can lead to reduced blood flow to the heart muscle. The condition progresses as the inner lining of the blood vessels becomes damaged and scarred. This scarring can cause the vessels to become stiff and less flexible. As the disease advances, it may affect the heart’s ability to function properly.

Trial ID:

2024-514023-42-00

Protocol code:

ACAV2018

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Alirocumab for Preventing Heart Vessel Disease in Recent Heart Transplant Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?