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

Ingrid Hopper; Thomas H. Marwick; Rory Wolfe; John Amerena; Andrea J. Curtis; Ben Freedman; Daniel J. Green; David M. Kaye; Amily Kolomoisky; John J. McNeil; Mark Nelson; Christopher M. Reid; Simone Spark; Andrew Tonkin; Bing H. Wang; Zhen Zhou; Sophia Zoungas

doi:10.1016/j.ahj.2025.06.004

June 12, 2025American Heart JournalOpen Access

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

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Why the study?

Statins may prevent aging-associated myocardial dysfunction, atrial fibrillation, and heart failure, but their effects on markers of cardiovascular aging in healthy older adults require assessment.

Does atorvastatin improve global longitudinal strain in healthy older individuals without prior cardiovascular disease events?

Structured PICO

Does atorvastatin improve global longitudinal strain in healthy older individuals without prior cardiovascular disease events?

P

Population

369 healthy older individuals ≥ 70 years without prior cardiovascular disease events, mean age 73.0 years

I

Intervention

Atorvastatin

C

Comparator

Placebo

O

Outcome

Change in global longitudinal strain (GLS) at 3 yearssurrogate

The STAREE-HEART trial will evaluate whether atorvastatin can prevent age-associated myocardial dysfunction, measured by global longitudinal strain, in healthy older adults.

Implication

Tests atorvastatin on cardiac aging markers in healthy adults ≥70; leaves open whether statins prevent AF/HF via myocardial effects.

Abstract

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.