Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07108075

Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis.

Led by Institute of Liver and Biliary Sciences, India · Updated on 2025-08-06

72

Participants Needed

1

Research Sites

19 weeks

Total Duration

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AI-Summary

What this Trial Is About

Clinically significant portal hypertension (CSPH) is defined as HVPG \>10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to \<12 mm Hg or reduction to \>20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Metformin has also recently showed to reduce portal pressure in a randomised control study. The mechanism of action of metformin is different from beta blockers (by increasing nitric oxide by upregulating iNOS and eNOS). Hence we are planning the current work to evaluate Acute portal pressure reduction by Metformin and Carvedilol compared to Carvedilol alone in cirrhosis - a randomised, double blind study.

CONDITIONS

Official Title

Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis.

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consecutive patients of cirrhosis with variceal bleed.
Not Eligible

You will not qualify if you...

  • Age less than 18 years or greater than 75 years.
  • Child-Turcotte-Pugh (CTP) Score 12 or higher.
  • Patients with cirrhosis who have not had variceal bleeding.
  • Use of metformin, nonselective beta-blockers, or carvedilol within the last 5 days.
  • Serum bilirubin level greater than 3 mg/dl.
  • Serum creatinine level greater than 1.5 mg/dl.
  • Contraindications to nonselective beta-blockers including heart rate below 60 per minute or blood pressure below 110/60 mm Hg.
  • History of asthma or heart failure.
  • Presence of portal vein thrombosis (PVT).
  • Diagnosis of hepatocellular carcinoma (HCC).
  • Hepatic encephalopathy grades 2 to 4.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India, 110070

Actively Recruiting

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Research Team

D

Dr Garvit Mundra, MD

CONTACT

D

Dr Chitranshu Vashishtha, DM

CONTACT

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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Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis. | DecenTrialz