Status:
RECRUITING
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Lead Sponsor:
Centro Cardiologico Monzino
Collaborating Sponsors:
Federico II University
Università Politecnica delle Marche
Conditions:
Arrhythmogenic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 l...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Known hypersensitivity to atorvastatin or any of the excipients
- Moderate or severe liver disease
- Muscle disease
- Left ventricular ejection fraction \<35%
- Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV.
- Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities
- Hypercholesterolemic patients that require the use of lipid lowering drugs.
- Heart transplantation
- Estimated life expectancy of less than 2 years
- 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
- Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals, Protease inhibitors , Gemfibrozil, Ciclosporin, Danazol
- Fusidic acid (drug for bacterial infections)
- Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination
- 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
- Drugs primary indicated as antioxidants
- 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.
- Pregnant or lactating women
- Women of childbearing age who are not using adequate contraception
- Known dependency on alcohol - drug abuse.
- Contraindications to cardiac magnetic resonance
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06922994
Start Date
March 31 2025
End Date
November 30 2026
Last Update
July 3 2025
Active Locations (5)
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1
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, PV, Italy, 27100
2
Università Politecnica delle Marche
Ancona, Italy, 60126
3
Centro Cardiologico Monzino IRCSS
Milan, Italy, 20138
4
AORN - Ospedali dei Colli
Napoli, Italy, 80131