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

NCT ID: NCT07108075

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-14
• Study Completion Date: 2025-10-30

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Metformin and Carvedilol

Metformin (1000 mg) Carvedilol (12.5 mg)

Group Type: EXPERIMENTAL

Carvedilol

Intervention Type: DRUG

Carvedilol 12. 5mg

Metformin

Intervention Type: DRUG

Metformin 1000 mg

Carvedilol

Carvedilol (12.5 mg)

Group Type: ACTIVE_COMPARATOR

Carvedilol

Intervention Type: DRUG

Carvedilol 12. 5mg

Interventions

Carvedilol

Carvedilol 12. 5mg

Intervention Type: DRUG

Metformin

Metformin 1000 mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr Garvit Mundra, MD

Role: CONTACT

garvitmundra@gmail.com

01146300000

Dr Chitranshu Vashishtha, DM

Role: CONTACT

chitranshuv@gmail.com

01146300000

Facility Contacts

Garvit Mundra, MD

Role: primary

garvitmundrailbs@gmail.com

01146300000

Other Identifiers

ILBS-ACLF-25

Identifier Type: -

Identifier Source: org_study_id