The Effect of Empagliflozin on Left Ventricular Mass and Volumes in Older Adult Individuals With Overweight and High Risk of Heart Failure: The Empire Prevent Cardiac Trial
Abstract
Background: Increased left ventricular (LV) mass is a predictor of heart failure (HF). The preventive effect of sodium-glucose cotransporter 2 inhibitors remains unclear in subjects without HF. The aim of this study was to evaluate the effect of empagliflozin on LV mass index (LVMI) and LV volumes in individuals with overweight and considered at risk of HF.
Method: An investigator-initiated, double-blinded, randomized, placebo-controlled, multicenter superiority trial [NCT05084235] comprised 191 older adult (60-84 years), overweight (body mass index [BMI] >28 kg/m2) individuals with at least 1 known risk factor for HF (hypertension, ischemic heart disease, stroke, chronic kidney disease). Study participants were randomized 1:1 to empagliflozin 10 mg or matching placebo for 180 days. Individuals with HF or type 2 diabetes were excluded. The primary endpoint was change in LVMI from baseline to 180 days assessed by cardiac magnetic resonance imaging, with between-group comparisons expressed as adjusted mean differences. Secondary endpoints were mean differences in changes in LV end-diastolic volume index (LVEDVI), LV end-systolic volume index (LVESVI), and LV ejection fraction (LVEF).
Results: Of the 191 randomized, 165 individuals (median age, 68 years; median BMI, 31.8 kg/m2; 67% were male; and median LVEF, 65%) completed MRI (empagliflozin: 83; placebo: 82). Empagliflozin reduced LVMI with an estimated treatment difference of -1.9 g/m2 (97.5% confidence interval [CI]: -3.5…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 165 participants or records.
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