STAREE-HEART: A randomized placebo-controlled trial of atorvastatin effects on a marker of cardiac aging in older individuals without prior cardiovascular disease events: Protocol and baseline description of participants

BACKGROUND: Statins may prevent myocardial dysfunction associated with aging, and consequent atrial fibrillation (AF) and heart failure (HF). STAREE-HEART is a randomized, double-blind, placebo-controlled clinical trial assessing atorvastatin on markers of cardiovascular aging in a healthy older population. This ancillary study is nested in the STAtins in Reducing Events in the Elderly (STAREE) primary prevention trial. METHODS: Participants ≥ 70 years (n = 369) have been randomized to atorvastatin or placebo. Assessment at baseline and 3-years includes echocardiogram, electrocardiography and blood collection for biomarker assessment. The primary endpoint is change in global longitudinal strain (GLS), a measure of left ventricular systolic function. An estimated 184 participants per group enables detection of mean GLS at 3 years in the placebo group being 2.0 percentage points lower than mean GLS in the statin group at 3 years, assuming SD = 5 percentage points and a 15% attrition rate, with power >90%. We present summary statistics describing participants at baseline. RESULTS: The mean age of the 369 STAREE-HEART participants was 73.0 years (SD 3.4). Mean left ventricular (LV) ejection fraction was 64.0% (SD 6.1), and mean GLS was 19.2% (SD 2.2). Mean GLS was similar between females and males (19.4% vs 19.0%) and slightly higher in those aged 70 to 74 compared to ≥75 years (19.4% vs 18.6%). AF was detected on screening in 4.5% of participants. CONCLUSION: The STAREE-HEART ancillary study will provide mechanistic detail concerning myocardial dysfunction and its consequences, to determine if atorvastatin affects left ventricular systolic function associated with aging. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov. Unique identifier: NCT04536870.