ELUCIDATE Trial: A Single-Center Randomized Controlled Study

J Am Heart Assoc. 2024 May 7;13(9):e033832. doi: 10.1161/JAHA.123.033832. Epub 2024 Apr 19.

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/m2.7 [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.

Keywords: clinical trial; dapagliflozin; echocardiography; sodium–glucose cotransporter 2 inhibitors; type 2 diabetes; ventricular remodeling.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Benzhydryl Compounds* / therapeutic use
  • Diabetes Mellitus, Type 2* / complications
  • Diabetes Mellitus, Type 2* / drug therapy
  • Echocardiography
  • Female
  • Glucosides* / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Natriuretic Peptide, Brain / blood
  • Peptide Fragments*
  • Prospective Studies
  • Sodium-Glucose Transporter 2 Inhibitors* / therapeutic use
  • Stroke Volume* / drug effects
  • Time Factors
  • Treatment Outcome
  • Ventricular Function, Left* / drug effects
  • Ventricular Remodeling* / drug effects

Substances

  • dapagliflozin
  • Benzhydryl Compounds
  • Glucosides
  • Sodium-Glucose Transporter 2 Inhibitors
  • Natriuretic Peptide, Brain
  • pro-brain natriuretic peptide (1-76)
  • Peptide Fragments

Associated data

  • ClinicalTrials.gov/NCT03871621