ELUCIDATE Trial: A Single-Center Randomized Controlled Study

Area of Science:

• Cardiology
• Endocrinology
• Pharmacology

Background:

• Type 2 diabetes (T2D) is associated with increased risk of cardiovascular complications.
• Sodium-glucose cotransporter 2 (SGLT2) inhibitors, like dapagliflozin, are established treatments for T2D and have shown cardiorenal benefits.
• The impact of early dapagliflozin intervention on left ventricular (LV) remodeling in T2D patients without pre-existing cardiovascular disease (CVD) is not well understood.

Purpose of the Study:

• To investigate the effect of early dapagliflozin add-on therapy on LV remodeling and cardiac function in patients with asymptomatic type 2 diabetes.
• To evaluate changes in LV dimensions, mass, and strain parameters following dapagliflozin treatment.
• To assess the potential of dapagliflozin in the primary prevention of diabetic cardiomyopathy.

Main Methods:

• The ELUCIDATE trial was a prospective, open-label, randomized study involving 76 patients with asymptomatic T2D and preserved LV ejection fraction (≥50%).
• Patients were randomized to receive dapagliflozin 10 mg/day add-on therapy or standard of care.
• Speckle-tracking echocardiography was used to measure cardiac global longitudinal strain at baseline and 24 weeks.

Main Results:

• Dapagliflozin treatment resulted in significant reductions in LV dimension, LV end-systolic volume, and LV mass index compared to standard care.
• Patients on dapagliflozin showed a significant increase in LV global longitudinal strain and improved systolic and early diastolic strain rates.
• No significant changes were observed in insulin resistance, NT-proBNP levels, or other biomarkers at 6 months.

Conclusions:

• Early dapagliflozin add-on therapy promotes favorable cardiac remodeling and enhances cardiac mechanical function in asymptomatic type 2 diabetes patients.
• These findings support the use of dapagliflozin for the primary prevention of diabetic cardiomyopathy.
• Dapagliflozin may offer a protective effect on the heart in T2D patients even before the onset of overt cardiovascular disease.