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EMPEROR - Reduced: EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure


Title A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).
Therapeutic Area Cardiomyopathy, Cardiac Failure, Heart Failure, Cardiovascular Disease
Principal Investigator Amanda Vest, MD
Min Age 18 Years
Gender All
Contact Angelo DeNofrio
617 636-9458
More Information https://clinicaltrials.gov/ct2/show/NCT03057977

Overview

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

Study Details

Inclusion Criteria

  • Has a Left Ventricular Ejection Fraction of >40%
  • Elevated BNP (blood test lab result)
  • ≥18 years of age

Exclusion Criteria

  • Have had a Heart Attack, a Stroke, or a Transient ischemic attack (TIA) in the last 90 days
  • Is taking empagliflozin (Jardiance®) for Diabetes
  • Have severe liver, kidney, or lung disease

Study Requirements

There will be 18 visits in total over a 34 month period (12 in person and 6 phone calls). In the first 4 months the participants will be seen in person 4 times. After the first 4 months the in person visits transition to being every 10 weeks, and after the first year the in person visits transition to every 12 weeks until end of treatment. The In Person Visits will take about 2 hours and may include all or some of the following:
  • A Physical Exam (e.g. Vitals, NYHA class, Height, Weight)
  • A review of the participants medications
  • 3 short questionnaires
  • A blood sample
  • Dispensing of study medication