ELUCIDATE Trial: A Single‐Center Randomized Controlled Study

Abstract

Background Dapagliflozin, a sodium–glucose cotransporter 2 inhibitor, is an epochal oral antidiabetic drug that improves cardiorenal outcomes. However, the effect of early dapagliflozin intervention on left ventricular (LV) remodeling in patients with type 2 diabetes free from cardiovascular disease remains unclear. Methods and Results The ELUCIDATE trial was a prospective, open‐label, randomized, active‐controlled study that enrolled 76 patients with asymptomatic type 2 diabetes with LV ejection fraction ≥50%, randomized to the dapagliflozin 10 mg/day add‐on or standard‐of‐care group. Speckle‐tracking echocardiography–based measurements of the cardiac global longitudinal strain were performed at baseline and 24 weeks after treatment initiation. Patients who received dapagliflozin had a greater reduction in LV dimension (1.68 mm [95% CI, 0.53–2.84]; P =0.005), LV end‐systolic volume (5.51 mL [95% CI, 0.86–10.17]; P =0.021), and LV mass index (4.25 g/m 2.7 [95% CI, 2.42–6.09]; P <0.0001) compared with standard of care in absolute mean differences. Dapagliflozin add‐on therapy led to a significant LV global longitudinal strain increment (0.74% [95% CI, 1.00–0.49]; P <0.0001) and improved LV systolic and early diastolic strain rates (0.27/s [95% CI, 0.17–0.60]; and 0.11/s [95% CI, 0.06–0.16], respectively; both P <0.0001) but not in global circumferential strain. No significant changes were found in insulin resistance, NT‐proBNP (N‐terminal pro‐B‐type natriuretic peptide) levels, or other biomarkers at 6 months after the dapagliflozin administration. Conclusions Dapagliflozin add‐on therapy could lead to more favorable cardiac remodeling accompanied by enhanced cardiac mechanical function among patients with asymptomatic type 2 diabetes. Our findings provide evidence of the efficacy of dapagliflozin use for the primary prevention of diabetic cardiomyopathy. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03871621.