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Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects (NCT03027960)

Boehringer Ingelheim
The investigators propose a small pilot proof of concept study to not only prove the existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin in patients with heart failure. The investigators propose a 50 patient randomized, double-blind, placebo-controlled crossover study with patients with stable HF, type II diabetes and an eGFR >45ml/min/1.73 m2 who are chronically receiving loop diuretics.
  • Drug: Empagliflozin
    10mg empagliflozin for a 2-week period
    • Drug: Placebo Oral Capsule
      10 mg placebo for a 2-week period
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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
      Study Objectives

      1. Study the acute/short term effect and cardio-renal mechanisms of sodium-glucose cotransporter 2 (SGLT2) inhibition in patients with heart failure.

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

      Primary Outcomes

      1. Aim 1 (Acute): Determine if acute SGLT2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo.

      2. Aim 2 (Chronic): Determine the effect of 14 days of SGLT2 inhibition on blood volume.

      1 locations

      United States (1)
      • Yale New Haven Hospital
        New Haven, Connecticut, United States, 06511
      Status:
      enrolling by invitation
      Type:
      Interventional
      Phase:
      Start:
      26 June, 2017
      Updated:
      26 June, 2017
      Participants:
      50
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