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EMPEROR-Reduced and EMPEROR-Preserved

The aim of the EMPEROR-Reduced, as well as the EMPEROR-Preserved studies is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure and either reduced ejection fraction or preserved ejection fraction.

Study objective:
This study evaluates the following outcome measures:

  • Time to first event of adjudicated CV (Cardiovascular) death or adjudicated HHF (Hospitalization for Heart Failure) in patients with Heart Failure with reduced or preserved Ejection Fraction (HFrEF).
  • Occurrence of adjudicated HHF.
  • eGRF (Estimated Glomerular filtration Rate), CKD-EPI (Chronic Kidney Disease-Epidemiology collaboration Equation), and cr slope of change from baseline.
  • Time to first occurrence of chronic dialysis or renal transplant or sustained reduction of eGFR.
  • Time to first adjudicated HHF.
  • Time to adjudicated CV death.
  • Time to all-cause mortality.
  • Time to onset of DM (Diabetes Mellitus).
  • Change from baseline in clinical summary score (Chronic Heart Failure symptom and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire at week 52.
  • Occurrence of all-cause hospitalization (first and recurrent) – time frame up to 38 months.
“While there are medications for the treatment of heart failure, 50% of patients with congestive heart failure will still die within 5 years. Thus, there is an unmet need for additional medications to treat heart failure. This medication, while invented for the treatment of diabetes, may have direct heart benefit, a premise that is being tested in these two trials.” Cara East, MD, principal investigator.

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria for the reduced ejection fraction study can be found at: https://www.clinicaltrials.gov/ct2/show/NCT03057977?term=NCT03057977&rank=1

A complete list of inclusion and exclusion criteria for the preserved ejection fraction study can be found at: https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT03057951&cntry=&state=&city=&dist=

Study contact: Merielle Boatman, MBA, BAAS, Merielle.Boatman@BSWHealth.org, 214.820.2273.

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