Metformin plus carvedilol versus carvedilol alone to lower portal pressure in cirrhosis

Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis - a Randomised, Double Blind Study.

This trial tests whether adding metformin to carvedilol lowers portal pressure more than carvedilol alone in adults with cirrhosis who have had variceal bleeding.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institute of Liver and Biliary Sciences, India (Academic / other)
• Locations: 1 site (New Delhi, National Capital Territory of Delhi)
• Trial ID: NCT07108075 on ClinicalTrials.gov

What this trial studies

This interventional study compares carvedilol alone to carvedilol plus metformin in adults with cirrhosis who present with variceal bleeding. Participants receive the assigned medication and undergo hepatic venous pressure gradient (HVPG) measurements to document acute changes in portal pressure. HVPG is derived from wedged and free hepatic venous pressures and is used here as a surrogate marker of portal hypertension and short‑term hemodynamic response. The trial is conducted at the Institute of Liver & Biliary Sciences in New Delhi and excludes patients with very advanced liver disease, significant renal dysfunction, hepatocellular carcinoma, or portal vein thrombosis.

Who should consider this trial

Good fit: Adults aged 18–75 with cirrhosis who present with variceal bleeding, are not currently on metformin or nonselective beta‑blockers, and who meet the study's laboratory and safety criteria are the intended participants.

Not a fit: Patients without recent variceal bleeding, those with Child‑Turcotte‑Pugh scores ≥12, significant renal impairment, active HCC or portal vein thrombosis, or contraindications to beta‑blockers or metformin are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding metformin could produce a larger immediate reduction in portal pressure and potentially lower the risk of recurrent variceal bleeding.

How similar studies have performed: Nonselective beta‑blockers such as carvedilol are established to lower portal pressure, but adding metformin for acute portal pressure reduction is a novel approach with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

\- Consecutive patients of cirrhosis with variceal bleed.

Exclusion Criteria:

1. Age \< 18 and \> 75yr,
2. CTP Score ≥12,
3. Patients of cirrhosis without variceal bleed,
4. Patients on metformin, nonselective β-blockers or carvedilol treatment within last 5 days,
5. S.Bilirubin \> 3 mg/dl,
6. S.creatinine 1.5 mg/dl,
7. Contraindications to NSBB (heart rate \< 60 /min, BP \< 110/60 mm Hg,
8. Asthma, heart failure),
9. PVT,
10. HCC
11. HE grades 2-4

Where this trial is running

New Delhi, National Capital Territory of Delhi

• Institute of Liver & Biliary Sciences (ILBS) — New Delhi, National Capital Territory of Delhi, India (Recruiting)

Study contacts

• Study coordinator: Dr Garvit Mundra, MD

Conditions Liver Cirrhosis