Trials / Recruiting
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
| Type | Name | Description |
|---|---|---|
| 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 |
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.