Liver cirrhosis
Conditions
Interventions
Study Group:Henagliflozin 10 mg orally once daily
Control Group:Standard treatment
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 75 years, any gender. 2) Diagnosis of cirrhosis: Evidence of impaired hepatocellular synthetic function or portal hypertension on imaging, biochemical, or hematological tests, or histological confirmation of cirrhosis. 3) Diagnosis of refractory ascites: 1) Lack of response to diuretic therapy (spironolactone 80–160 mg/day and furosemide 40–80 mg/day) for >1 week, or lack of response after 2 weeks of repeated therapeutic paracentesis combined with human albumin infusion. 2) Intolerance to escalation of diuretic dosage; 3) Occurrence of difficult-to-control diuretic-related complications or adverse events; Exclusion of malignant ascites and ascites caused by pre-sinusoidal portal hypertension. The diagnosis should meet criterion 1, 2, or 3, together with criterion 4. 4) Diagnosis of refractory hydrothorax: 1) Imaging confirmation: chest X-ray, chest CT, or thoracic ultrasound confirming pleural effusion, with assessment of volume (small, moderate, or large); 2) Optimized treatment of the underlying disease: guideline-recommended or maximally tolerated therapy has been administered for the suspected or confirmed primary cause (e.g., heart failure, cirrhosis/portal hypertension, malignancy, renal failure, hypoalbuminemia, postoperative or inflammatory conditions) for an adequate duration (e.g., several days of standardized therapy for heart failure or hepatic hydrothorax, or ongoing/previous systemic therapy for malignant pleural effusion), yet significant pleural effusion or symptoms persist; 3) Persistent symptomatic moderate-to-large pleural effusion: despite optimized etiologic treatment, imaging shows moderate or larger effusion (estimated to occupy >= approximately one-third of the ipsilateral hemithorax), accompanied by symptoms such as dyspnea; 4) Rapid reaccumulation: recurrence of moderate or larger pleural effusion within 7 days after adequate therapeutic thoracentesis or drainage, causing symptoms; 5) Frequent therapeutic thoracentesis: requiring >=2 therapeutic thoracenteses within 30 days, each providing only temporary relief followed by recurrence. The diagnosis should meet criteria 1 and 2, together with any one of criteria 3, 4, or 5. 5) Patients with cirrhosis and concomitant type 2 diabetes (T2D) are allowed to be enrolled, provided that the following conditions are met: 1) The antidiabetic regimen is stable for >=7 days (no significant adjustments in oral hypoglycemic agents, GLP-1 receptor agonists, insulin, etc.); 2) HbA1c <=11% (if higher, adherence and risk of diabetic ketoacidosis should be evaluated by the investigator); 3) Stable 24-hour urinary sodium excretion prior to treatment initiation (variation <20% over two consecutive days); 4) No use of SGLT2 inhibitors within 2 weeks before study enrollment. 6) Ability to provide informed consent independently.
Exclusion criteria
Exclusion criteria: 1.Systolic blood pressure 20 or expected median survival 1000 ng/mL within 3 months, or LVEF <40%. 14.History of bladder dysfunction, severe benign prostatic hyperplasia, or urinary incontinence. 15.Urinary tract infection within the past 3 months, or evidence of urinary tract infection at screening (e.g., pyelonephritis or cystitis). 16.History of fungal vaginitis, balanitis, or balanoposthitis within the past 3 months. 17.Serum sodium <125 mmol/L. 18.Symptomatic hypoglycemia within the past 3 months. 19.Participation in other clinical trials. 20.Patients currently being evaluated for liver transplantation or who have received liver transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractional Excretion of Sodium;24 h urinary sodium excretion;24 h urine volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pleural and ascitic fluid volume;Body weight and abdominal circumference;Changes in urinary creatinine, spot urinary sodium/potassium, and quantitative urinary glucose excretion;Plasma renin activity (PRA), total renin (TR), angiotensin II (Ang II), plasma aldosterone concentration (PAC), norepinephrine (NE), and antidiuretic hormone (AVP);Volume-related biomarkers (B-type natriuretic peptide [BNP]); | — |
Countries
China
Contacts
Public ContactSun Wei
The First Affiliated Hospital of Soochow University
Outcome results
None listed