Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

About this trial

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 criteria

Qualifiers

Participant must be at least 18 years of age, at the time of signing the informed consent

Participants affected by Arrhythmogenic Cardiomyopathy as defined by task force criteria

Disqualifiers

Known hypersensitivity to atorvastatin or any of the excipients

Moderate or severe liver disease

Muscle disease

Left ventricular ejection fraction <35%

Trial design

Treatments tested in this trial

  • Atorvastatin 80 mg/day
  • Placebo atorvastatin

Treatment groups

102 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centro Cardiologico Monzino

Lead sponsor

Federico II University

Collaborator

Università Politecnica delle Marche

Collaborator

Ospedali dei Colli

Collaborator