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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
10mg empagliflozin for a 2-week period
10 mg placebo for a 2-week period
Yale New Haven Hospital
New Haven, Connecticut, United States
urine sodium concentrations via ion selective electrodes
Determine if acute SGLT2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo. Measuring the natriuretic effect of a loop diuretic (placebo v acute SGLT2 inhibition) via urine sodium output.
Time frame: 36 days
blood volume
Determine the effect of 14 days of SGLT2 inhibition on blood volume. Daxor Blood Volume Sample Collection 1. Volumex Injection: The Volumex tracer (radiolabeled albumin) is injected as an intravenous bolus (IV-push). (As soon as the tracer injection begins, a stopwatch is started and never zeroed out. Running times are used for the entire procedure). 2. Serial Blood Collection A series of 5 post-Volumex blood samples is collected, after tracer injection, allowing for complete mixing in the bloodstream. 3. Sample Timing: Samples are ideally spaced \~6 minutes apart, and are collected approximately 12, 18, 24, 30 and 36 minutes after Volumex administration.
Time frame: 14 days
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