SOLOIST-WHF Trial
ClinicalTrials.gov Identifier: NCT03521934
Full Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter
Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in
HemodynamIcally STable Patients with Type 2 Diabetes POST Worsening
Heart Failure
Sponsor: Sanofi
Condition:
Heart Failure-Type 2 Diabetes Mellitus
Interventional Clinical Trial
Treatments:
Sotagliflozin vs Placebo
Purpose
Primary Objective:
•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.
Secondary Objectives:
•To demonstrate that, when compared to placebo in the toal patient population, sotagliflozin reduces the total number (i.e., including recurrent events) of the following clinical events:
•Cardiovascular death, HHF or urgent HF visit.
•To demonstrate that, when compared to placebo, sotagliflozin reduces:
•The composite of positively adjudicated sustained ≥50% decrease in eGFR, chronic dialysis, renal transplant or positively adjudicated sustained eGFR <15 mL/min/1.73 m2 in the total patient population.
•Cardiovascular death in patients with LVEF < 50%.
•Cardiovascular death in the total patient population.
•All-cause mortality in patients with LVEF < 50%.
•All cause mortality in the total patient population.
•To demonstrate the safety and tolerability of sotagliflozin in the total population in this study.
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