Effectiveness and Safety of Atorvastatin 80 mg in Treating Arrhythmogenic Cardiomyopathy A Phase 2 Randomized Study Comparing Atorvastatin to Placebo Over 18 Months

What this Trial Is About

Researchers are evaluating whether Atorvastatin 80 mg can prevent worsening of right ventricular function and other heart-related changes in patients with Arrhythmogenic Cardiomyopathy. The study also aims to assess the safety of Atorvastatin 80 mg in this patient group by comparing it with a placebo. Important questions include if the drug prevents electrical, structural, and biomarker deterioration and what medical issues may occur during treatment. Participants will be randomly assigned to take either Atorvastatin 80 mg or a placebo daily for 18 months. The study includes 51 patients in each group affected by Arrhythmogenic Cardiomyopathy. During the study, participants will visit the clinic at enrollment and after 2, 4, 9, and 18 months for various tests and checkups. Safety follow-up phone calls will be conducted at 12, 15, and 19 months, and participants will complete psychological questionnaires. Throughout the study, researchers will monitor heart function, electrical activity, structural changes, arrhythmias, and biomarkers related to heart health from enrollment through 18 months of treatment. Safety will be assessed up to one month after treatment ends 19 months. This includes detailed heart imaging and blood tests to track disease progression and any effects of the drug. The total participation lasts about 19 months with ongoing safety monitoring and assessments.

Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)