Actively Recruiting
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Led by Centro Cardiologico Monzino · Updated on 2025-07-03
102
Participants Needed
5
Research Sites
87 weeks
Total Duration
On this page
Sponsors
C
Centro Cardiologico Monzino
Lead Sponsor
F
Federico II University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Known hypersensitivity to atorvastatin or any of the excipients
- Moderate or severe liver disease
- Muscle disease
- Left ventricular ejection fraction less than 35%
- Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
- Known cardiomyopathy of other origin including post ischemic, hypertrophic, idiopathic dilated, restrictive
- Known moderate-to-severe mitral or aortic valvulopathy
- Pulmonary hypertension
- Congenital cardiac abnormalities
- Hypercholesterolemic patients requiring lipid lowering drugs
- Heart transplantation
- Estimated life expectancy less than 2 years
- Any medical condition that places the patient at risk, makes them unreliable, or limits study completion
- Use of potent CYP3A4 modifiers such as Erythromycin, Clarithromycin, Azole antifungals, Protease inhibitors, Gemfibrozil, Ciclosporin, Danazol
- Use of Fusidic acid
- Use of Hepatitis C antivirals like telaprevir, boceprevir, glecaprevir/pibrentasvir, ledipasvir/sofosbuvir
- Use of other lipid lowering drugs such as Statins, Cholesterol absorption inhibitors, Bile acid sequestrants, PCSK9 inhibitors, ATP-citrate lyase inhibitors, Fibrates, Omega-3 fatty acid ethyl esters
- Use of drugs primarily indicated as antioxidants
- Enrollment in another clinical trial or past trial with investigational drug within 30 days or 5 half-lives
- Pregnant or lactating women
- Women of childbearing age not using adequate contraception
- Known dependency on alcohol or drug abuse
- Contraindications to cardiac magnetic resonance
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, PV, Italy, 27100
Actively Recruiting
2
Università Politecnica delle Marche
Ancona, Italy, 60126
Actively Recruiting
3
Centro Cardiologico Monzino IRCSS
Milan, Italy, 20138
Actively Recruiting
4
AORN - Ospedali dei Colli
Naples, Italy, 80131
Actively Recruiting
5
Università degli Studi di Napoli Federico II
Naples, Italy, 80138
Not Yet Recruiting
Research Team
E
Elena Sommariva
CONTACT
C
Claudio Tondo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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