ATORVASTATIN for Arrhythmogenic Cardiomyopathy (ACM) | Arrhythmogenic right ventricular cardiomyopathy

Inclusion criteria

• {"criterion_text":"- Diagnosis of ACM based on the 2010 Task Force criteria or Padua Criteria"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Signed the informed consent"}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to atorvastatin or any of the excipients"}
• {"criterion_text":"- Moderate or severe liver disease (persistent elevation of transaminases more than 3 times the upper limit of the normal laboratory reference range)"}
• {"criterion_text":"- Left ventricular ejection fraction <35%"}
• {"criterion_text":"- Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV"}
• {"criterion_text":"- Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral and/or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities"}
• {"criterion_text":"- Heart transplantation"}
• {"criterion_text":"- Estimated life expectancy of less than 2 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals (e.g. itraconazole, posaconazole, voriconazole) Protease inhibitors (e.g. ritonavir, telaprevir, boceprevir), Gemfibrozil, Ciclosporin, Danazol"}
• {"criterion_text":"- Fusidic acid (drug for bacterial infections)"}
• {"criterion_text":"- Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination"}
• {"criterion_text":"- Any other lipid lowering drugs such as Statins (Atorvastatin, Fluvastatin, Lovastatin, Pravastatin, Rosuvastatin, Simvastatin) Cholesterol absorption inhibitors (Ezetimibe), Bile acid sequestrants (Cholestyramine, Colestipol), PCSK9 inhibitors (Alirocumab, Evolucumab), Adenosine triphosphate-citrate lyase inhibitors (Bempedoic acid), Fibrates (Gemfibrozil, Fenofibrate, Bezafibrate), Omega-3 fatty acid ethyl esters"}
• {"criterion_text":"- Drugs with antioxidant effects (N-acetyl-cysteine)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Pregnant or lactating women"}
• {"criterion_text":"- Women of childbearing age who are not using adequate contraception that complies with local regulations on methods of contraception for clinical trial participants"}
• {"criterion_text":"- Known dependency on alcohol – drug abuse"}

Primary endpoints

• {"endpoint_text":"- Deterioration from baseline of RV free wall longitudinal strain measured by ECHO","definition_or_measurement_approach":"Measured by echocardiography (ECHO); change from baseline in right ventricular free wall longitudinal strain."}

Secondary endpoints

• {"endpoint_text":"- Deterioration from baseline of i) arrhythmia burden (PVC, non-sustained and sustained VA, VF, appropriate ICD shocks); ii) other morphological parameters (ventricular volumes, function, both at ECHO and CMR); iii) ECG parameters; iv) blood parameters","definition_or_measurement_approach":"Arrhythmia burden assessed by recording PVC, non-sustained/sustained ventricular arrhythmias, VF, appropriate ICD shocks; morphological parameters assessed by ECHO and CMR (ventricular volumes, function); ECG parameters and blood biomarkers measured per protocol."}
• {"endpoint_text":"- Monitoring of AE","definition_or_measurement_approach":"Adverse events monitored and recorded throughout the study per safety reporting procedures."}

Italy

Earliest CTIS Part Ii Submission Date

28-08-2024

Latest Decision Or Authorization Date

14-04-2025

Processing Time Days

229

Number Of Sites

4

Number Of Participants

102

Primary sponsor

Full Name

Centro Cardiologico Monzino S.p.A.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Euromed Pharma Services S.r.l.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Universita' Degli Studi Di Napoli Federico II","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Educational Institution"}
• {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"sponsorDuties codes: 1; 15 (Pharmacovigilance); 8","organisation_type":"Pharmaceutical company"}