Heart Failure With Preserved Ejection Fraction (EMPEROR- Preserved)

In by Natalie Parker

Heart Failure With Preserved Ejection Fraction (EMPEROR- Preserved)

  • This field is for validation purposes and should be left unchanged.

 

  • The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction.
clinicaltrials.gov

Eligibility

Inclusion Criteria
  • Male or female patient, age ≥ 18 years at screening
  • Patients with Chronic Heart Failure NYHA class II-IV and preserved Ejection Fraction > 40 % and elevated NT-proBNP > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF
  • Structural heart disease within 6 months prior to Visit 1, OR documented Hospitalization for Heart Failure within 12 months
Exclusion Criteria
  • Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or Transient Ischemic Attack in past 90 days
  • Heart transplant recipient or listed for heart transplant
  • Systolic blood pressure (SBP) ≥ 180 mmHg at Visit 2
  • Symptomatic hypotension and/or a SBP < 100 mmHg
  • Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 or requiring dialysis
  • History of ketoacidosis
  • Current use or prior use of a SGLT -2 inhibitor or combined SGLT-1 and 2 inhibitor [canagliflozin (Invokana), dapagliflozin (Farxiga), empagliflozin (Jardiance), empagliflozin/linagliptin (Glyxambi), empagliflozin/metformin (Synjardy), dapagliflozin/metformin (Xigduo XR)]
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