Actively Recruiting
Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis - a Randomised, Double Blind Study
Led by Institute of Liver and Biliary Sciences, India · Updated on 2025-08-06
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for liver cirrhosis patients who have clinically significant portal hypertension (CSPH), a condition that increases the risk of serious complications like variceal bleeding and liver decompensation. This randomized, double-blind study aims to compare the effects of Metformin combined with Carvedilol versus Carvedilol alone on reducing portal pressure. The study focuses on measuring changes in hepatic venous pressure gradient (HVPG), which helps assess the severity and risk related to portal hypertension. Participants will receive either Metformin (1000 mg) plus Carvedilol (12.5 mg) or Carvedilol (12.5 mg) alone. These treatments are given to evaluate their immediate impact on portal pressure. The study is designed to observe acute changes within 2 hours after drug administration. Both groups will be monitored for changes in blood sugar, inflammatory markers, liver and spleen stiffness, and cardiac output. During the study, participants will have HVPG measurements taken to track the primary outcome of a significant decrease in portal pressure. Additional assessments include evaluating inflammatory markers and organ stiffness. The trial includes detailed monitoring of heart rate and blood pressure to ensure safety. Participation duration covers the acute assessment period following treatment, with close observation for any immediate effects during the 2-hour post-dose window.
CONDITIONS
Brief Title
Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consecutive patients of cirrhosis with variceal bleed
- Age between 18 and 75 years
You will not qualify if you...
- Age less than 18 or greater than 75 years
- Child-Turcotte-Pugh (CTP) Score 12 or higher
- Cirrhosis patients without variceal bleed
- Use of metformin, nonselective beta-blockers, or carvedilol within last 5 days
- Serum bilirubin greater than 3 mg/dl
- Serum creatinine greater than 1.5 mg/dl
- Contraindications to nonselective beta-blockers (heart rate less than 60/min, blood pressure less than 110/60 mm Hg)
- Asthma or heart failure
- Portal vein thrombosis (PVT)
- Hepatocellular carcinoma (HCC)
- Hepatic encephalopathy grades 2 to 4
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 hours
Participants receive either Metformin and Carvedilol or Carvedilol alone to reduce portal pressure in cirrhosis.
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070
Actively Recruiting
Research Team
D
Dr Garvit Mundra, MD
D
Dr Chitranshu Vashishtha, DM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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