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

2 1 1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Centro Cardiologico Monzino S.p.A. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Politecnica Delle Marche Ancona Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
01.10.2024

Trial locations

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.

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 ID:
2024-514643-28-00
Protocol code:
SEARCH
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on Spironolactone for Patients with Arrhythmogenic Right Ventricular Dysplasia (ARVD)

    Recruiting

    2 1 1
    Investigated drugs:
    France