Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Heart Failure Clinical Trial

Official 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

Status Terminated

Clinical Trial Summary

Primary Objective:

To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF)

Secondary Objectives:

To compare the effects of sotagliflozin to placebo on:

• The total occurrences of HHF and urgent visit for HF

• The occurrence of CV death

• The occurrence of all-cause mortality

• The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke

• Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score

• Change in estimated glomerular filtration rate (eGFR)

Clinical Trial Description

The estimated study duration for a given participants will be approximately 3 to 24 months. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Type 2 Diabetes Mellitus

• NCT number: NCT03521934
• Study type: Interventional
• Source: Lexicon Pharmaceuticals
• Status: Terminated
• Phase: Phase 3
• Start date: June 15, 2018
• Completion date: June 5, 2020