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| ID | Type | Description | Link |
|---|---|---|---|
| PNRR-MCNT2-2023-12376978 | Other Grant/Funding Number | European Union - NextGenerationEU | |
| 2024-514643-28-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Federico II University | OTHER |
| Università Politecnica delle Marche | OTHER |
| Ospedali dei Colli | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator | Atorvastatin arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy. |
|
| Placebo | Placebo Comparator | Placebo arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 80 mg/day | Drug | Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Atorvastatin in avoiding functional right ventricular deterioration | Variation of right ventricular free wall longitudinal strain measured by echocardiography after 18 months respect to baseline (%) | From enrollment to the end of treatment at 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Atorvastatin treatment | Monitoring of adverse events and patient's well-being. | From enrollment to 1 month after the end of treatment (19 months) |
| Efficacy of Atorvastatin in avoiding morphological deterioration (ventricular volumes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Sommariva | Contact | +39 0258002752 | elena.sommariva@cardiologicomonzino.it | |
| Claudio Tondo | Contact | +39 0258002275 | claudio.tondo@cardiologicomonzino.it |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Tondo | Centro Cardiologico Monzino IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione I.R.C.C.S. Policlinico San Matteo | Recruiting | Pavia | PV | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34337880 | Background | 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. |
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| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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This is a multicenter, prospective, randomized, clinical study: Atorvastatin 80mg/day or placebo will be administered for 18 months to 102 ACM patients, and the endpoints will be tested.
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| Placebo atorvastatin | Drug | One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy |
|
Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: ventricular volumes (ml)
| From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding morphological deterioration (wall thickness ) | Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: wall thickness (mm) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding morphological deterioration (cardiac function ) | Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: cardiac function (%) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding arrhythmic deterioration (premature ventricular contractions) | Deterioration from baseline of arrhythmia burden: premature ventricular contractions (number in the 24h) | From enrollment to the end of treatment at 18 months |
| Efficacy of Atorvastatin in avoiding arrhythmic deterioration (nonsustained ventricular arrhythmias) | Deterioration from baseline of arrhythmia burden: nonsustained ventricular arrhythmias (number) | From enrollment to the end of treatment at 18 months |
| Efficacy of Atorvastatin in avoiding arrhythmic deterioration (sustained ventricular arrhythmias) | Deterioration from baseline of arrhythmia burden: sustained ventricular arrhythmias (number) | From enrollment to the end of treatment at 18 months |
| Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ventricular fibrillation ) | Deterioration from baseline of arrhythmia burden: ventricular fibrillation (number) | From enrollment to the end of treatment at 18 months |
| Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ICD shocks) | Deterioration from baseline of arrhythmia burden: appropriate ICD shocks (number) | From enrollment to the end of treatment at 18 months |
| Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QRS) | Deterioration from baseline of electrocardiographic parameters: QRS duration (ms) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QT) | Deterioration from baseline of electrocardiographic parameters: QT duration (ms) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (PR) | Deterioration from baseline of electrocardiographic parameters: PR duration (ms) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (amplitudes) | Deterioration from baseline of electrocardiographic parameters: amplitude of the potential (mV) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (T wave) | Deterioration from baseline of electrocardiographic parameters: ), T wave inversion (number of presences in V1-V6) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (ԑ wave) | Deterioration from baseline of electrocardiographic parameters: ԑ wave in V1-V3 (presence) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (oxLDL) | Deterioration from baseline of blood parameters: oxLDL (mU/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (MDA) | Deterioration from baseline of blood parameters: MDA (ng/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (4HNE) | Deterioration from baseline of blood parameters: 4HNE (pg/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (estradiol) | Deterioration from baseline of blood parameters: estradiol (pg/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (testosterone) | Deterioration from baseline of blood parameters: testosterone (ng/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (BIN1) | Deterioration from baseline of blood parameters: BIN1 (pg/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (GAL3) | Deterioration from baseline of blood parameters: GAL3 (ng/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (HSP70) | Deterioration from baseline of blood parameters: HSP70 (ng/mL) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (TGFb) | Deterioration from baseline of blood parameters: TGFb (pg/mL) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (ST2) | Deterioration from baseline of blood parameters: ST2 (ng/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (BNP) | Deterioration from baseline of blood parameters: BNP (pg/mL) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (NTproBNP) | Deterioration from baseline of blood parameters: NTproBNP (pg/mL) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (hs-cTnI) | Deterioration from baseline of blood parameters: hs-cTnI (ng/L) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (CRP) | Deterioration from baseline of blood parameters: CRP (mg/L) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (IL6) | Deterioration from baseline of blood parameters: IL6 (pg/ml) | From enrollment to the end of treatment (18 months) |
| Efficacy of Atorvastatin in avoiding biomarkers deterioration (TNF alfa) | Deterioration from baseline of blood parameters: TNF alfa (pg/ml) | From enrollment to the end of treatment (18 months) |
| Università Politecnica delle Marche | Recruiting | Ancona | 60126 | Italy |
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| Centro Cardiologico Monzino IRCSS | Recruiting | Milan | 20138 | Italy |
|
| AORN - Ospedali dei Colli | Recruiting | Naples | 80131 | Italy |
|
| Università degli Studi di Napoli Federico II | Not yet recruiting | Naples | 80138 | Italy |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |