Metformin plus carvedilol versus carvedilol alone to lower portal pressure in cirrhosis
Official title: Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis - a Randomised, Double Blind Study.
Run by Institute of Liver and Biliary Sciences, India · NCT07108075 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | June 14, 2025 |
| Main results expected | October 30, 2025 |
| Study ends | October 30, 2025 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT07108075 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Study coordinator: Dr Garvit Mundra, MD
- Email: garvitmundra@gmail.com
- Phone: 01146300000
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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.