NCT07108075 Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis.
| NCT ID | NCT07108075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Condition | Liver Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-06-14 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-06-14 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07108075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07108075 currently recruiting?
Yes, NCT07108075 is actively recruiting participants. Contact the research team at garvitmundra@gmail.com for enrollment information.
Where is the NCT07108075 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT07108075 clinical trial?
NCT07108075 is sponsored by Institute of Liver and Biliary Sciences, India. The trial plans to enroll 72 participants.