Atorvastatin 80 mg to slow progression of arrhythmogenic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, double-blind, placebo-controlled trial gives adults with arrhythmogenic cardiomyopathy either atorvastatin 80 mg daily or a matching placebo for 18 months. Participants attend clinic visits at baseline and 2, 4, 9, and 18 months with additional safety phone checks, and undergo imaging, electrical testing, and biomarker sampling to track disease progression. The primary focus is on preventing right ventricular functional deterioration, with secondary assessments of electrical, morphological, and biomarker changes. Safety and adverse events related to high-dose atorvastatin in this population are recorded throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione I.R.C.C.S. Policlinico San Matteo
  Pavia, Pv, Italy Recruiting
• Università Politecnica delle Marche
  Ancona, Italy Recruiting
• Centro Cardiologico Monzino IRCSS
  Milan, Italy Recruiting
• AORN - Ospedali dei Colli
  Naples, Italy Recruiting
• Università degli Studi di Napoli Federico II
  Naples, Italy Not yet recruiting

Study contacts

• Principal investigator: Claudio Tondo — Centro Cardiologico Monzino IRCCS
• Study coordinator: Elena Sommariva
• Email: elena.sommariva@cardiologicomonzino.it
• Phone: +39 0258002752

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• S-ICD Eligibility Over Time in Arrhythmogenic Cardiomyopathy

  This study checks whether adults with arrhythmogenic cardiomyopathy stay eligible for a subcutaneous ICD over 18 months.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07849764

• T1 mapping to characterize heart tissue in common heart diseases

  This project tests whether T1 mapping MRI scans, including dye-free native T1, can define normal and disease-specific heart tissue values for adults with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing, Beijing Municipality · NCT07354646

• Assessing patient characteristics and clinical course for those with PKP2-ACM

  This study looks at the experiences and health changes of people with PKP2-ACM over time to better understand the condition and its impact on their lives.

  Recruiting at 6 sites Lexeo Therapeutics · Redwood City, California and 5 other locations · NCT06976606

• Identifying patients with cardiomyopathy for potential heart transplantation

  This study is trying to find new ways to identify and understand cardiomyopathy in patients to better predict if they might need a heart transplant in the future.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Emilia-Romagna/Bologna and 2 other locations · NCT06813443

• Predicting Ventricular Tachycardia Events in Patients with Non-Ischemic Cardiomyopathy

  This study is trying to see if certain heart imaging tests can help predict the risk of dangerous heart rhythms and sudden cardiac death in people with non-ischemic cardiomyopathy.

  Recruiting at 4 sites Centro Medico Teknon · Milan, Italy and 3 other locations · NCT06730464

• Understanding Arrhythmogenic Cardiomyopathy and its Treatment

  This study is trying to learn more about Arrhythmogenic Cardiomyopathy by collecting health information and samples from patients to see how the condition behaves and what the long-term outcomes are.

  Recruiting First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shaanxi · NCT06352307

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.