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SOLOIST

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 - SOLOIST-WHF Trial

  • Clinical Trial Information

    Trial Contact: Noel, Henry; Anthony, Susan; Peisner, Pamela; Tinetti, Meghan

  • IRB No: 18.173.12

    Protocol Abbrev: SOLOIST-WHF-Trial

    Principal Investigator: Sushma Koneru, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: EFC15156

    Treatment: Drug: Sotagliflozin (SAR439954) Drug: Placebo

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT03521934

  • Objective

    1.Cardiovascular (CV) death or hospitalization for heart failure (HHF) [ Time Frame: Baseline to approximately 32 months ]
    Time to first occurrence of either cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with left ventricular ejection fraction (LVEF) <50%

    2.Cardiovascular (CV) death or hospitalization for heart failure (HHF) [ Time Frame: Baseline to approximately 32 months ]
    Time to first occurrence of either CV death or HHF in the total patient population

  • Key Eligibility

    Between Age 18-85
    Type 2 Diabetes
    Admitted to the hospital with worsening heart failure
    Prior chronic treatment with loop diuretic