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Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites

NCT06919523 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-04-09

No results posted yet for this study

Summary

The aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patients with cirrhotic refractory ascites. The main question it aims to answer is the difference in ascites control between the two groups at the end of treatment defined as:

Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. Researchers will compare intervention group receiving dapagliflozin 5m once daily for 3 months along with standard care versus standard care group to evaluate the effectiveness and safety of dapagliflozin in refractory ascites patients.

Conditions

  • Refractory Ascites

Interventions

DRUG

Dapagliflozin 5mg

Dapagliflozin 5m orally once daily for 3 months plus standard care (diuretics and Large volume paracentesis)

DRUG

Standard care treatment

Diuretics and Large volume paracentesis as indicated

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2025-08-15
Completion
2025-09-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06919523 on ClinicalTrials.gov