Empagliflozin in Patients With Cirrhosis and Ascites
A legfontosabb adatok
- Hol
- New Haven (Egyesült Államok)A helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Yale UniversityNew Haven, Egyesült ÁllamokContact: Jeffrey TestaniRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Yale University
- Azonosító
- NCT05726032
- A regiszteradat frissítve
- 2026. szeptember 14.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites
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.
Bevonási feltételek: 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.
Kizáró feltételek: Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis); Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance; Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor; Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks; Previous liver transplant; Participation in another trial with an investigational drug within the 30 days prior to informed consent; Change in diuretic dose in the prior 2 weeks; Active malignancy including hepatocellular carcinoma undergoing treatment; History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections; Type 1 diabetes; History of frequent hypoglycemic episodes; Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease); Patients with hospitalization for alcoholic hepatitis in the past 6 months; Direct bilirubin >=3 mg/dL; Significant worsening of creatinine (more than 50% increase) in the past 4 weeks; Hemoglobin <8; Systolic blood pressure < 100 mmHg; Hepatic encephalopathy grade II or greater at the time of enrollment; Patients who have had TIPS placed; Pregnancy or breastfeeding; MELD-Na > or equal to 20.