A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
20
Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.
Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.
Yale University
New Haven, Connecticut, United States
RECRUITINGChange in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)
Change in fractional excretion of sodium with administration of study drug (10 mg empagliflozin vs. identical placebo)
Time frame: 14 days
Change in total body water (TBW) before and after a 14-day course of study drug
Change in total body water (TBW) before and after a 14-day course of study drug (10 mg/day empagliflozin vs. identical placebo)
Time frame: 14 days
Change in renal blood flow before and after administration of study drug
Change in renal blood flow (RBF) as determined by PAH clearance, before and after the acute administration of study drug ((RPF assessed using ancillary protocol on page 31)
Time frame: Baseline to Hour 6
Change in plasma renin activity,total renin, aldosterone, norepinephrine and copeptin
Change in plasma renin activity (PRA), total renin, aldosterone, norepinephrine and copeptin before and after a 14-day course of study drug
Time frame: 14 days
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