Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2018 |
| Start Date: | June 27, 2017 |
| End Date: | June 2022 |
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.
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.
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. 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.
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
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