Arrhythmogenic CardiomyopathyPhase 2SEARCHNCT06922994
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
A Phase 2 study testing Atorvastatin 80 mg/day in people with Arrhythmogenic Cardiomyopathy, run by Centro Cardiologico Monzino at 5 sites in Italy.
Trial 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 learn about the safety of Atorvastatin 80 mg in this type of patients. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmogenic Cardiomyopathy
- What is being tested?
- Atorvastatin 80 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 5 sitesItaly
- Study dates
- 31 Mar 2025to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Università Politecnica delle Marche
Ancona, 60126
Michela Casella, +39 0715965324, m.casella@staff.univpm.it
- Recruiting
Centro Cardiologico Monzino IRCSS
Milan, 20138
Claudio Tondo, +39 0258002275, claudio.tondo@cardiologicomonzino.it
- Recruiting
AORN - Ospedali dei Colli
Naples, 80131
Giuseppe Limongelli, +39 0817062211, giuseppe.limongelli@ospedalideicolli.it
- Not yet recruiting
Università degli Studi di Napoli Federico II
Naples, 80138
Raffaella Lombardi, +39 081676541, raffaella.lombardi@unina.it
- Recruiting
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, PV, 27100
Annalisa Turco, +390382503158, A.Turco@smatteo.pv.it
About this study
Official title: Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression
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:
- Does Atorvastatin 80 mg prevent worstening of the right ventricular functioning?
- Does Atorvastatin 80 mg prevent the worsening of electric, morphological and biomarkers deterioration?
- What medical problems do participants have when taking Atorvastatin 80 mg?
Read more
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:
- Take Atorvastatin 80 mg or a placebo every day for 18 months;
- Visit the clinic at the enrollment and after 2, 4, 9 and 18 months for checkups and tests;
- Make a phone call for safety check after 12, 15 and 19 months since the enrollment;
- Fill out psychological questionnaires
- Conditions
- Arrhythmogenic Cardiomyopathy
- Being tested
- Atorvastatin 80 mg/day, Placebo atorvastatin
- Keywords
- Atorvastatin, Strain, Disease progression risk, Arrhythmias
- Medical subject headings
- Sprains and Strains, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80 mg/dayDrug
Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
Placebo atorvastatinDrug
One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Atorvastatin arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy. Receives: Drug: Atorvastatin 80 mg/day |
| Placebo | Placebo comparator | Placebo arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy. Receives: Drug: Placebo atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: From enrollment to the end of treatment at 18 months
Secondary outcomes (31)
Safety of Atorvastatin treatment
Monitoring of adverse events and patient's well-being.
Measured: From enrollment to 1 month after the end of treatment (19 months)
Efficacy of Atorvastatin in avoiding morphological deterioration (ventricular volumes)
Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: ventricular volumes (ml)
Measured: 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)
Measured: 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 (%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From enrollment to the end of treatment (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start31 Mar 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arrhythmogenic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, Università Politecnica delle Marche, Ospedali dei Colli
- Responsible party
- Sponsor
- Investigators
- Claudio Tondo, Principal investigator, Centro Cardiologico Monzino IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922994
- Sponsor's protocol ID
- SEARCH
- Other IDs
- PNRR-MCNT2-2023-12376978, 2024-514643-28-00
- Acronym
- SEARCH
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34337880Sommariva E, Lippi M, Bruttini F, Cannata F, Baggiano A, Schiavone M, Salina G, Sabatino M, Vettor G, Sicuso R, Pizzamiglio F, Ribatti V, Maragna R, Carbucicchio C, DeLuca F, Catto V, Iezzi A, Sale EO, Valeri Y, Barbarossa A, Caiazza M, Monda E, Frisso G, Borrelli F, Gasperetti A, Turco A, De Luca L, Corino VDA, Galotta A, Bonomi A, Pompilio G, Pontone G, Muratori M, Limongelli G, Lombardi R, Casella M, Tondo C. Statin effect on arrhythmogenic cardiomyopathy disease progression (SEARCH): Randomized clinical study protocol. PLoS One. 2025 Sep 29;20(9):e0332876. doi: 10.1371/journal.pone.0332876. eCollection 2025.
PubMed 41021550
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression
- ClinicalTrials.gov ID
- NCT06922994
- Acronym / sponsor ID
- SEARCH / SEARCH
- Conditions
- Arrhythmogenic Cardiomyopathy
- Keywords
- Atorvastatin, Strain, Disease progression risk, Arrhythmias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Federico II University, Università Politecnica delle Marche, Ospedali dei Colli
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Atorvastatin 80 mg prevent worstening of the right ventricular functioning?
- Does Atorvastatin 80 mg prevent the worsening of electric, morphological and biomarkers deterioration?
- 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:
- Take Atorvastatin 80 mg or a placebo every day for 18 months;
- Visit the clinic at the enrollment and after 2, 4, 9 and 18 months for checkups and tests;
- Make a phone call for safety check after 12, 15 and 19 months since the enrollment;
- Fill out psychological questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin 80 mg/dayAtorvastatin arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy. |
| Placebo | Placebo comparator | Drug: Placebo atorvastatinPlacebo arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 80 mg/dayAtorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy | Drug | Atorvastatin |
| Placebo atorvastatinOne tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy | Drug | Placebo |
Primary outcome
Efficacy of Atorvastatin in avoiding functional right ventricular deterioration
Time frame: From enrollment to the end of treatment at 18 months
Variation of right ventricular free wall longitudinal strain measured by echocardiography after 18 months respect to baseline (%)
31 secondary outcomes
Safety of Atorvastatin treatment
Time frame: From enrollment to 1 month after the end of treatment (19 months)
Efficacy of Atorvastatin in avoiding morphological deterioration (ventricular volumes)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding morphological deterioration (wall thickness )
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding morphological deterioration (cardiac function )
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding arrhythmic deterioration (premature ventricular contractions)
Time frame: From enrollment to the end of treatment at 18 months
Efficacy of Atorvastatin in avoiding arrhythmic deterioration (nonsustained ventricular arrhythmias)
Time frame: From enrollment to the end of treatment at 18 months
Efficacy of Atorvastatin in avoiding arrhythmic deterioration (sustained ventricular arrhythmias)
Time frame: From enrollment to the end of treatment at 18 months
Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ventricular fibrillation )
Time frame: From enrollment to the end of treatment at 18 months
Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ICD shocks)
Time frame: From enrollment to the end of treatment at 18 months
Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QRS)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QT)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (PR)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (amplitudes)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (T wave)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (ԑ wave)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (oxLDL)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (MDA)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (4HNE)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (estradiol)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (testosterone)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (BIN1)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (GAL3)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (HSP70)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (TGFb)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (ST2)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (BNP)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (NTproBNP)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (hs-cTnI)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (CRP)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (IL6)
Time frame: From enrollment to the end of treatment (18 months)
Efficacy of Atorvastatin in avoiding biomarkers deterioration (TNF alfa)
Time frame: From enrollment to the end of treatment (18 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 34337880Sommariva 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.
- Derived from this study: PubMed 41021550Sommariva E, Lippi M, Bruttini F, Cannata F, Baggiano A, Schiavone M, Salina G, Sabatino M, Vettor G, Sicuso R, Pizzamiglio F, Ribatti V, Maragna R, Carbucicchio C, DeLuca F, Catto V, Iezzi A, Sale EO, Valeri Y, Barbarossa A, Caiazza M, Monda E, Frisso G, Borrelli F, Gasperetti A, Turco A, De Luca L, Corino VDA, Galotta A, Bonomi A, Pompilio G, Pontone G, Muratori M, Limongelli G, Lombardi R, Casella M, Tondo C. Statin effect on arrhythmogenic cardiomyopathy disease progression (SEARCH): Randomized clinical study protocol. PLoS One. 2025 Sep 29;20(9):e0332876. doi: 10.1371/journal.pone.0332876. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudio Tondo principal investigator
Centro Cardiologico Monzino IRCCS
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 80 mg/day in people with Arrhythmogenic Cardiomyopathy, run by Centro Cardiologico Monzino at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Sommariva (+39 0258002752, elena.sommariva@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Atorvastatin in avoiding functional right ventricular deterioration (time frame: From enrollment to the end of treatment at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06922994, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.