Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Boehringer Ingelheim
• Treatments: Diuretics; Empagliflozin

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