Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects (EMPA)

Trial Purpose and Description

i. Study the acute/short term effect and cardio-renal mechanisms of SGLT2 inhibition in patients with heart failure.

ii. Determine the effect of chronic combined SLLGT2 and loop diuretic exposure in patients with heart failure.

Ages: 18 years and older

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Stable HF as defined by:
  • No hospitalization for >60 days
  • Stable HF medications for >=2 weeks, and stable diuretics for 4 weeks
  • Opinion of HF cardiologist that the patient is at their optimal volume status
  • Chronic daily oral loop diuretic dose >=20mg furosemide equivalents
  • Diagnosis of type II diabetes
  • Patient monitors blood glucose regularly at home
  • eGFR >=45 mL/min/1.73 m2
  • >=18 years old

Exclusion Criteria:

  • Active titration of chronic HF medications expected during the study period
  • Use of a non-loop diuretic, aside from an aldosterone antagonist (<=25mg spironolactone or <=50mg eplerenone)
  • Critical stenotic valvular disease, complex congenital heart disease, or prior heart transplant
  • History of diabetic ketoacidosis, "brittle" diabetes, and/or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
  • History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
  • Anemia (defined as hemoglobin <8g/dL)
  • Pregnancy or breastfeeding
  • History of serious hypersensitivity
  • Participation in another trial with an investigational drug within the 30 days prior to informed consent
  • Use of another SGLT-2 inhibitor
  • Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research RN (ex: clinically-significant psychiatric, addictive, or neurological disease)
  • Inability to give written informed consent or follow study protocol

Boehringer Ingelheim Pharmaceuticals, Inc.

Dates: 04/19/2017 - 10/31/2018

Last Updated: 06/15/2017

Study HIC#: 2000020019

Get Involved

For more information about this study, contact:
Jennifer Lynn Tainsh
jennifer.tainsh@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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