Overview
Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects
Status:
Completed
Completed
Trial end date:
2019-06-01
2019-06-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Yale UniversityCollaborator:
Boehringer IngelheimTreatments:
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