SOLOIST-WHF

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Cardioprotective Effects of SOtagLiflozin in HemOdynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart Failure - SOLOIST-WHF

Objective

The primary objectives of this trial are:

  • To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF) with left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart failure (WHF).
  • To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with T2D and HF irrespective of LVEF after admission for WHF.

Eligibility

  • Type 2 Diabetes Mellitus
  • Admitted to the hospital, or urgent heart failure visit for worsening heart failure
  • Prior diagnosis of heart failure (> 3 months)
  • Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for > 30 days
  • Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge
  • Brain natriuretic peptide (BNP) ≥150 pg/mL (≥450 pg/mL for patients with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for patients with atrial fibrillation)
  • Patients with Left Ventricular Ejection Fraction <40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated

NCT ID

NCT03521934