Statin effect on arrhythmogenic cardiomyopathy disease progression (SEARCH): Randomized clinical study protocol

Area of Science:

• Cardiology
• Genetics
• Pharmacology

Background:

• Arrhythmogenic cardiomyopathy (ACM) is an inherited heart condition causing arrhythmias and sudden death.
• Current treatments manage symptoms but do not halt disease progression, necessitating new therapies.
• Elevated oxidized low-density lipoprotein (oxLDL) correlates with advanced ACM, and atorvastatin reduced disease in a mouse model.

Purpose of the Study:

• To evaluate the efficacy of atorvastatin in preventing ACM progression.
• To assess if atorvastatin's benefits stem from lipid-lowering or pleiotropic effects (antioxidant, anti-inflammatory).
• To explore atorvastatin's impact on arrhythmic burden and cardiac function in ACM patients.

Main Methods:

• The SEARCH trial is a prospective, randomized, double-blind, placebo-controlled study (NCT06922994).
• 102 ACM patients will receive either atorvastatin 80mg/day or placebo for 18 months.
• Primary outcome: change in right ventricular global longitudinal strain; secondary outcomes: arrhythmic burden, cardiac indices, biomarkers.

Main Results:

• This section is to be filled after the study's completion.

Conclusions:

• This trial will provide crucial data on atorvastatin's potential as a disease-modifying therapy for ACM.
• Findings may inform future large-scale studies and establish a new treatment strategy to improve patient outcomes.
• The study addresses a significant unmet need for therapies that slow ACM progression.