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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07108075
Enrollment
72
Registered
2025-08-06
Start date
2025-06-14
Completion date
2025-10-30
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

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.

Interventions

DRUGCarvedilol

Carvedilol 12. 5mg

DRUGMetformin

Metformin 1000 mg

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
HVPG response (decrease by ≥ 20 % from baseline or < 12 mmHg).2 hours

Secondary

MeasureTime frame
Reduction in HVPG in both groups.2 hours
Change in blood sugar level after 2 hours of the drug in both groups.2 hours
HVPG decrease by ≥ 10% in both groups.2 hours
Change in liver and spleen stiffness.2 hours
Change in cardiac output in both groups.2 hours
Change in inflammatory markers (IL-10, TNF α, i-NOS, e-NOS) in both groups.2 hours

Countries

India

Contacts

Primary ContactDr Garvit Mundra, MD
garvitmundra@gmail.com01146300000
Backup ContactDr Chitranshu Vashishtha, DM
chitranshuv@gmail.com01146300000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026