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Study on the Effect of Atorvastatin in Slowing Down Arrhythmogenic Cardiomyopathy Progression in Patients with the Condition

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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 atorvastatin on a heart condition known as Arrhythmogenic Cardiomyopathy (ACM). ACM is a disease that affects the heart muscle, leading to irregular heartbeats and potentially causing heart failure. The trial aims to evaluate whether atorvastatin, a drug commonly used to lower cholesterol, can help reduce or delay the progression of this heart condition.

Participants in the study will be given atorvastatin in the form of film-coated tablets, which are taken orally. The study will also include a group of participants who will receive a placebo. The main goal is to see if atorvastatin can prevent the worsening of the heart's right ventricle, which is a part of the heart that can be affected by ACM. The study will monitor various health indicators, including heart function and rhythm, using methods like echocardiograms (ECHO) and blood tests.

The trial will take place over a period of time, with regular check-ups to assess the participants' heart health and any changes in their condition. The study is designed to provide valuable information on whether atorvastatin can be an effective treatment option for people with ACM, potentially improving their quality of life by managing the progression of the disease.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, ensure that the diagnosis of arrhythmogenic cardiomyopathy (ACM) is confirmed based on the 2010 Task Force criteria.

    Confirm that you are 18 years or older and have signed the informed consent form.

  2. Step 2

    Medication administration

    You will be given atorvastatin in the form of film-coated tablets. Each tablet contains 80 mg of the medication.

    Take the tablet orally as directed by the study team. The frequency and duration of administration will be specified by the study team.

  3. Step 3

    Monitoring and assessments

    Regular assessments will be conducted to monitor the progression of the condition. This includes measuring the function of the right ventricle (RV) using an ultrasound of the heart, known as an ECHO.

    Additional tests may include monitoring heart rhythm, checking heart structure and function through imaging tests, and evaluating blood parameters.

  4. Step 4

    End of study

    The study is expected to conclude by August 31, 2026. You will be informed about the results and any further steps if necessary.

Who can join the trial?

3 criteria

  • Must have a diagnosis of Arrhythmogenic Cardiomyopathy (ACM) based on the 2010 Task Force criteria. This means a doctor has confirmed you have ACM using specific guidelines from 2010.
  • Must be 18 years or older.
  • Must have signed the informed consent. This means you have agreed to participate in the study after being informed about it.

Who cannot join the trial?

4 criteria

  • Patients with a history of **Arrhythmogenic Cardiomyopathy (ACM)** cannot participate. This is a condition where the heart muscle is replaced by fat and scar tissue, which can lead to heart rhythm problems.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, cannot participate.
  • Patients who do not meet the specific health criteria set by the study cannot participate. These criteria are designed to ensure the safety and effectiveness of the study.
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Investigated drugs

Atorvastatin is a medication commonly used to lower cholesterol levels in the blood. In this clinical trial, it is being tested to see if it can help prevent the worsening of heart function in people with a specific heart condition called arrhythmogenic cardiomyopathy. This condition affects the right side of the heart, and the study aims to find out if atorvastatin can slow down or stop the heart from getting worse over time.

What is already known about the treatment

Atorvastatin – Atorvastatin is taken orally in the form of a tablet. It is currently being studied for its potential benefits in treating Arrhythmogenic Cardiomyopathy (ACM), a heart condition. The main goal of using Atorvastatin in this context is to prevent the worsening of the right side of the heart. At the molecular level, Atorvastatin works by blocking an enzyme in the liver that is responsible for making cholesterol, which can help reduce inflammation and improve heart function. It is classified as a statin, a type of medication commonly used to lower cholesterol levels in the blood.

Investigated diseases

Arrhythmogenic Cardiomyopathy (ACM) – Arrhythmogenic Cardiomyopathy is a heart disease that affects the muscle of the heart, particularly the right ventricle. It is characterized by the replacement of heart muscle with fibrous or fatty tissue, which can disrupt the normal electrical signals in the heart. This disruption can lead to irregular heartbeats, known as arrhythmias. Over time, the structural changes in the heart muscle can lead to a decrease in the heart's ability to pump blood effectively. The disease often progresses with an increase in arrhythmia burden, changes in heart structure, and alterations in heart function. Monitoring of heart function and structure is crucial to understanding the progression of this condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514643-28-00Protocol codeSEARCHEstimated enrolment102 patientsSponsorCentro Cardiologico Monzino S.p.A.

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