Using Dapagliflozin to help manage ascites in cirrhosis
Official title: "Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"
Run by Beni-Suef University · NCT07684326 · Data updated 2026-11-12
This study tests whether adding dapagliflozin to standard care helps people with cirrhosis and ascites reduce fluid buildup and improve outcomes.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Giza) |
| Status | Recruiting |
| Started | July 2026 |
| Main results expected | July 2027 |
| Study ends | September 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07684326 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ with cirrhosis and ascites who have recent or current hospital admission and meet the inclusion/exclusion criteria.
✕Probably not a fit
Patients with severe liver dysfunction (e.g., Child-Pugh C) or significant comorbidities may not benefit and could be at higher risk of adverse effects.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares standard care for cirrhosis with ascites to standard care plus dapagliflozin. It includes adults with liver cirrhosis and ascites who have been hospitalized, randomizing them to either continue standard diuretics and procedures or add dapagliflozin at adjusted doses based on liver disease severity. Participants are monitored for hydration, infections, weight, electrolyte levels, and quality of life, with follow-up visits to assess safety and responses. The study aims to see if dapagliflozin can reduce large-volume paracentesis needs, ICU admissions, and mortality, while potentially lowering costs and improving quality of life.
Why it matters
Potential benefit: If successful, patients could experience better control of ascites and fewer hospitalizations.
How similar studies have gone: Previous studies in related conditions show promise for SGLT2 inhibitors in fluid management, but this is a relatively novel application in cirrhosis with ascites.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients 18 years of age and older with a diagnosis of liver cirrhosis with any degree of ascites that led to previous or recent hospital admission (determined by clinical findings and imaging) will be included in the study. Exclusion Criteria: 1. Child Pugh score ≥ 12 or MELD score \> 25. 2. Previous history of hypoglycemia or has a previous history of DKA. 3. Blood pressure less than 90/60 or need dose of midodrine \>15 mg/day. 4. Previous history of recurrent urinary tract infections (more than 2 infections in the last 6 months) or anatomic urologic defects that predispose to urinary tract infection. 5. Pregnant or lactating female patients. 6. Hypersensitivity to dapagliflozin. 7. eGFR \< 30 ml/min/1.73 m2 8. Had hepatocellular carcinoma or any malignancy. 9. Serum sodium level \< 125 mg/dl. 10. Portal vein thrombosis.
Where it's running
-
Haram Hospital
Giza, Egypt Recruiting
Study contacts
- Study coordinator: Raghda Roshdy
- Email: Raghda.hussien@pharm.bsu.edu.eg
- Phone: +0282-2162135
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.