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NCT Number: NCT06922994

Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

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. 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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, PV, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Atorvastatin 80 mg/day

Drug

Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy

Placebo atorvastatin

Drug

One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy

Primary outcomes

  1. 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 (%)

Secondary outcomes

  1. Safety of Atorvastatin treatment

    Time frame: From enrollment to 1 month after the end of treatment (19 months)

    Monitoring of adverse events and patient's well-being.

  2. Efficacy of Atorvastatin in avoiding morphological deterioration (ventricular volumes)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: ventricular volumes (ml)

  3. Efficacy of Atorvastatin in avoiding morphological deterioration (wall thickness )

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: wall thickness (mm)

  4. Efficacy of Atorvastatin in avoiding morphological deterioration (cardiac function )

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: cardiac function (%)

  5. Efficacy of Atorvastatin in avoiding arrhythmic deterioration (premature ventricular contractions)

    Time frame: From enrollment to the end of treatment at 18 months

    Deterioration from baseline of arrhythmia burden: premature ventricular contractions (number in the 24h)

  6. Efficacy of Atorvastatin in avoiding arrhythmic deterioration (nonsustained ventricular arrhythmias)

    Time frame: From enrollment to the end of treatment at 18 months

    Deterioration from baseline of arrhythmia burden: nonsustained ventricular arrhythmias (number)

  7. Efficacy of Atorvastatin in avoiding arrhythmic deterioration (sustained ventricular arrhythmias)

    Time frame: From enrollment to the end of treatment at 18 months

    Deterioration from baseline of arrhythmia burden: sustained ventricular arrhythmias (number)

  8. Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ventricular fibrillation )

    Time frame: From enrollment to the end of treatment at 18 months

    Deterioration from baseline of arrhythmia burden: ventricular fibrillation (number)

  9. Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ICD shocks)

    Time frame: From enrollment to the end of treatment at 18 months

    Deterioration from baseline of arrhythmia burden: appropriate ICD shocks (number)

  10. Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QRS)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of electrocardiographic parameters: QRS duration (ms)

  11. Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QT)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of electrocardiographic parameters: QT duration (ms)

  12. Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (PR)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of electrocardiographic parameters: PR duration (ms)

  13. Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (amplitudes)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of electrocardiographic parameters: amplitude of the potential (mV)

  14. Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (T wave)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of electrocardiographic parameters: ), T wave inversion (number of presences in V1-V6)

  15. Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (ԑ wave)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of electrocardiographic parameters: ԑ wave in V1-V3 (presence)

  16. Efficacy of Atorvastatin in avoiding biomarkers deterioration (oxLDL)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: oxLDL (mU/ml)

  17. Efficacy of Atorvastatin in avoiding biomarkers deterioration (MDA)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: MDA (ng/ml)

  18. Efficacy of Atorvastatin in avoiding biomarkers deterioration (4HNE)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: 4HNE (pg/ml)

  19. Efficacy of Atorvastatin in avoiding biomarkers deterioration (estradiol)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: estradiol (pg/ml)

  20. Efficacy of Atorvastatin in avoiding biomarkers deterioration (testosterone)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: testosterone (ng/ml)

  21. Efficacy of Atorvastatin in avoiding biomarkers deterioration (BIN1)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: BIN1 (pg/ml)

  22. Efficacy of Atorvastatin in avoiding biomarkers deterioration (GAL3)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: GAL3 (ng/ml)

  23. Efficacy of Atorvastatin in avoiding biomarkers deterioration (HSP70)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: HSP70 (ng/mL)

  24. Efficacy of Atorvastatin in avoiding biomarkers deterioration (TGFb)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: TGFb (pg/mL)

  25. Efficacy of Atorvastatin in avoiding biomarkers deterioration (ST2)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: ST2 (ng/ml)

  26. Efficacy of Atorvastatin in avoiding biomarkers deterioration (BNP)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: BNP (pg/mL)

  27. Efficacy of Atorvastatin in avoiding biomarkers deterioration (NTproBNP)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: NTproBNP (pg/mL)

  28. Efficacy of Atorvastatin in avoiding biomarkers deterioration (hs-cTnI)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: hs-cTnI (ng/L)

  29. Efficacy of Atorvastatin in avoiding biomarkers deterioration (CRP)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: CRP (mg/L)

  30. Efficacy of Atorvastatin in avoiding biomarkers deterioration (IL6)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: IL6 (pg/ml)

  31. Efficacy of Atorvastatin in avoiding biomarkers deterioration (TNF alfa)

    Time frame: From enrollment to the end of treatment (18 months)

    Deterioration from baseline of blood parameters: TNF alfa (pg/ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Claudio Tondo

CONTACT

[email protected]

+39 0258002275

Elena Sommariva

CONTACT

[email protected]

+39 0258002752

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Collaborators

  • Federico II University
  • Ospedali dei Colli
  • Università Politecnica delle Marche

Registry information

Official study title

Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression

Acronym: SEARCH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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