{ "data": { "asOf": "2026-10-30T22:27:22.829Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06922994", "title": "Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)", "scientificTitle": "Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Arrhythmogenic Cardiomyopathy" ], "interventions": [ { "name": "Atorvastatin 80 mg/day", "type": "DRUG", "description": "Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy" }, { "name": "Placebo atorvastatin", "type": "DRUG", "description": "One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy" } ], "sponsor": { "name": "Centro Cardiologico Monzino", "type": "OTHER" }, "locations": [ { "city": "Pavia", "country": "Italy", "facility": "Fondazione I.R.C.C.S. Policlinico San Matteo" }, { "city": "Ancona", "country": "Italy", "facility": "Università Politecnica delle Marche" }, { "city": "Milan", "country": "Italy", "facility": "Centro Cardiologico Monzino IRCSS" }, { "city": "Naples", "country": "Italy", "facility": "AORN - Ospedali dei Colli" }, { "city": "Naples", "country": "Italy", "facility": "Università degli Studi di Napoli Federico II" } ], "outcomes": { "other": [], "primary": [ "Efficacy of Atorvastatin in avoiding functional right ventricular deterioration" ], "secondary": [ "Safety of Atorvastatin treatment", "Efficacy of Atorvastatin in avoiding morphological deterioration (ventricular volumes)", "Efficacy of Atorvastatin in avoiding morphological deterioration (wall thickness )", "Efficacy of Atorvastatin in avoiding morphological deterioration (cardiac function )", "Efficacy of Atorvastatin in avoiding arrhythmic deterioration (premature ventricular contractions)", "Efficacy of Atorvastatin in avoiding arrhythmic deterioration (nonsustained ventricular arrhythmias)", "Efficacy of Atorvastatin in avoiding arrhythmic deterioration (sustained ventricular arrhythmias)", "Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ventricular fibrillation )", "Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ICD shocks)", "Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QRS)", "Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QT)", "Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (PR)", "Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (amplitudes)", "Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (T wave)", "Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (ԑ wave)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (oxLDL)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (MDA)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (4HNE)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (estradiol)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (testosterone)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (BIN1)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (GAL3)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (HSP70)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (TGFb)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (ST2)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (BNP)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (NTproBNP)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (hs-cTnI)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (CRP)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (IL6)", "Efficacy of Atorvastatin in avoiding biomarkers deterioration (TNF alfa)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Participant must be at least 18 years of age, at the time of signing the informed consent\n2. Participants affected by Arrhythmogenic Cardiomyopathy as defined by task force criteria\n\nExclusion Criteria:\n\n1. Known hypersensitivity to atorvastatin or any of the excipients\n2. Moderate or severe liver disease\n3. Muscle disease\n4. Left ventricular ejection fraction \\<35%\n5. Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV.\n6. Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities\n7. Hypercholesterolemic patients that require the use of lipid lowering drugs.\n8. Heart transplantation\n9. Estimated life expectancy of less than 2 years\n10. 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\n11. Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals, Protease inhibitors , Gemfibrozil, Ciclosporin, Danazol\n12. Fusidic acid (drug for bacterial infections)\n13. Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination\n14. 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\n15. Drugs primary indicated as antioxidants\n16. 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.\n17. Pregnant or lactating women\n18. Women of childbearing age who are not using adequate contraception\n19. Known dependency on alcohol - drug abuse.\n20. 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