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Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

NCT06922994 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-07-03

No results posted yet for this study

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. 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

Conditions

  • Arrhythmogenic Cardiomyopathy

Interventions

DRUG

Atorvastatin 80 mg/day

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

DRUG

Placebo atorvastatin

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

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER

  • Università Politecnica delle Marche

    collaborator OTHER

  • Ospedali dei Colli

    collaborator OTHER

  • Centro Cardiologico Monzino

    lead OTHER

Principal Investigators

  • Claudio Tondo · Centro Cardiologico Monzino IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922994 on ClinicalTrials.gov