Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
NCT ID: NCT06922994
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
102 participants
INTERVENTIONAL
2025-03-31
2026-11-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Atorvastatin
Atorvastatin arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy.
Atorvastatin 80 mg/day
Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
Placebo
Placebo arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy.
Placebo atorvastatin
One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
Interventions
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Atorvastatin 80 mg/day
Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
Placebo atorvastatin
One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
Eligibility Criteria
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Inclusion Criteria
2. Participants affected by Arrhythmogenic Cardiomyopathy as defined by task force criteria
Exclusion Criteria
2. Moderate or severe liver disease
3. Muscle disease
4. Left ventricular ejection fraction \<35%
5. Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV.
6. Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities
7. Hypercholesterolemic patients that require the use of lipid lowering drugs.
8. Heart transplantation
9. Estimated life expectancy of less than 2 years
10. 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
11. Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals, Protease inhibitors , Gemfibrozil, Ciclosporin, Danazol
12. Fusidic acid (drug for bacterial infections)
13. Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination
14. 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
15. Drugs primary indicated as antioxidants
16. 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.
17. Pregnant or lactating women
18. Women of childbearing age who are not using adequate contraception
19. Known dependency on alcohol - drug abuse.
20. Contraindications to cardiac magnetic resonance
18 Years
ALL
No
Sponsors
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Federico II University
OTHER
Università Politecnica delle Marche
OTHER
Ospedali dei Colli
OTHER
Centro Cardiologico Monzino
OTHER
Responsible Party
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Principal Investigators
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Claudio Tondo
Role: PRINCIPAL_INVESTIGATOR
Centro Cardiologico Monzino IRCCS
Locations
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Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, PV, Italy
Università Politecnica delle Marche
Ancona, , Italy
Centro Cardiologico Monzino IRCSS
Milan, , Italy
AORN - Ospedali dei Colli
Napoli, , Italy
Università degli Studi di Napoli Federico II
Napoli, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Sommariva E, Stadiotti I, Casella M, Catto V, Dello Russo A, Carbucicchio C, Arnaboldi L, De Metrio S, Milano G, Scopece A, Casaburo M, Andreini D, Mushtaq S, Conte E, Chiesa M, Birchmeier W, Cogliati E, Paolin A, Konig E, Meraviglia V, De Musso M, Volani C, Cattelan G, Rauhe W, Turnu L, Porro B, Pedrazzini M, Camera M, Corsini A, Tondo C, Rossini A, Pompilio G. Oxidized LDL-dependent pathway as new pathogenic trigger in arrhythmogenic cardiomyopathy. EMBO Mol Med. 2021 Sep 7;13(9):e14365. doi: 10.15252/emmm.202114365. Epub 2021 Aug 2.
Other Identifiers
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PNRR-MCNT2-2023-12376978
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-514643-28-00
Identifier Type: CTIS
Identifier Source: secondary_id
SEARCH
Identifier Type: -
Identifier Source: org_study_id
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