Health TrialsbyHealthPanel

Empagliflozin in Patients With Cirrhosis and Ascites

ConditionsCirrhosisLiver Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses

eGFR >= 30mL/min/1.73 m2

>=18 years old

Disqualifiers

Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)

Direct bilirubin >=3 mg/dL

Systolic blood pressure < 100 mmHg

Active malignancy including hepatocellular carcinoma undergoing treatment

Trial design

Design model

Crossover

Treatments tested in this trial

  • Empagliflozin 10 MG

    Drug

    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.

  • Matching Placebo

    Drug

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: EmpagliflozinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change 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

Secondary outcomes

1

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
2

Change in total renin, aldosterone, norepinephrine

Change in total renin, aldosterone, norepinephrine before and after a 14-day course of study drug

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Boehringer Ingelheim

Collaborator

Source ClinicalTrials.gov
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