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RecruitingNCT06922994

Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
102 (estimated)
Sponsor
Centro Cardiologico Monzino · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGAtorvastatin 80 mg/dayAtorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
DRUGPlacebo atorvastatinOne tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy

Timeline

Start date
2025-03-31
Primary completion
2026-11-30
Completion
2026-11-30
First posted
2025-04-11
Last updated
2025-07-03

Locations

5 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT06922994. Inclusion in this directory is not an endorsement.