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Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

Recruiting
18 years and older
All
Phase 2

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Overview

The goal of this clinical trial is to learn if Atorvastatin 80 mg is effective to avoid functional right ventricular deterioration in patients affected by Arrhythmogenic Cardiomyopathy. It will also learn about the safety of Atorvastatin 80 mg in this type of patients. The main questions it aims to answer are:

  1. Does Atorvastatin 80 mg prevent worstening of the right ventricular functioning?
  2. Does Atorvastatin 80 mg prevent the worsening of electric, morphological and biomarkers deterioration?
  3. What medical problems do participants have when taking Atorvastatin 80 mg?

Researchers will compare Atorvastatin 80 mg to a placebo (a look-alike substance that contains no drug) to see if the drug works to treat Arrhythmogenic Cardiomyopathy.

Participants will:

  1. Take Atorvastatin 80 mg or a placebo every day for 18 months;
  2. Visit the clinic at the enrollment and after 2, 4, 9 and 18 months for checkups and tests;
  3. Make a phone call for safety check after 12, 15 and 19 months since the enrollment;
  4. Fill out psychological questionnaires

Eligibility

Inclusion Criteria:

  1. Participant must be at least 18 years of age, at the time of signing the informed consent
  2. Participants affected by Arrhythmogenic Cardiomyopathy as defined by task force criteria

Exclusion Criteria:

  1. Known hypersensitivity to atorvastatin or any of the excipients
  2. Moderate or severe liver disease
  3. Muscle disease
  4. Left ventricular ejection fraction <35%
  5. Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV.
  6. Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities
  7. Hypercholesterolemic patients that require the use of lipid lowering drugs.
  8. Heart transplantation
  9. Estimated life expectancy of less than 2 years
  10. Any other medical condition that, in the judgment of the investigator, places the patient at risk or makes the patient unreliable or limits the patient's ability to complete the study
  11. Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals, Protease inhibitors , Gemfibrozil, Ciclosporin, Danazol
  12. Fusidic acid (drug for bacterial infections)
  13. Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination
  14. Any other lipid lowering drugs such as Statins, Cholesterol absorption inhibitors, Bile acid sequestrants , PCSK9 inhibitors, Adenosine triphosphate-citrate lyase inhibitors , Fibrates, Omega-3 fatty acid ethyl esters
  15. Drugs primary indicated as antioxidants
  16. Enrollment in another clinical trial or past clinical trial in which an investigational drug was administered within 30 days of Visit 1 or within the 5 half-lives of the investigational drug, whichever is longer.
  17. Pregnant or lactating women
  18. Women of childbearing age who are not using adequate contraception
  19. Known dependency on alcohol - drug abuse.
  20. Contraindications to cardiac magnetic resonance

Study details
    Arrhythmogenic Cardiomyopathy

NCT06922994

Centro Cardiologico Monzino

12 July 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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