Randomised clinical study: acute effects of metformin versus placebo on portal pressure in patients with cirrhosis and portal hypertension.
Nikolaj Rittig, Niels Kristian Aagaard, Gerda Elisabeth Villadsen...
https://pubmed.ncbi.nlm.nih.gov/34165199Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06687265
Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension A Randomized Placebo-controlled Study
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-13
76
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Portal hypertension is a condition where pressure between the portal vein and hepatic veins is elevated, leading to serious complications in people with cirrhosis. This study focuses on patients with cirrhosis who have a high hepatic venous pressure gradient (HVPG) of 12 mm Hg or more, which increases the risk of variceal bleeding. Researchers aim to evaluate whether adding metformin to the standard carvedilol treatment can reduce this pressure more effectively than a placebo. Participants will be randomly assigned to receive either metformin or a placebo pill twice daily for 28 days, in addition to their existing carvedilol treatment. The study is designed as a national, multicenter, phase II, randomized, placebo-controlled trial with two parallel groups. The main focus is to compare the effects of metformin versus placebo on HVPG after 28 days. During the study, participants will have their HVPG measured to assess changes. Researchers will also monitor safety, tolerability, liver and spleen stiffness using elastography, systemic hemodynamics, liver steatosis, and markers of inflammation, coagulation, and liver cell stress. The total participation lasts at least 28 days, with follow-up assessments to evaluate treatment effects and safety.
CONDITIONS
Brief Title
Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Written informed consent to participate in the study
- Medical insurance coverage
- For women of childbearing age, use of contraception such as hormonal, intrauterine device, or mechanical methods
- Diagnosis of cirrhosis by liver biopsy or clinical, biological, endoscopic, and radiological evidence
- Active cause of cirrhosis or resolution for at least 6 months
- Child-Pugh class A or B
- High likelihood of hepatic venous pressure gradient (HVPG) ≥ 12 mm Hg based on investigator judgment or specific clinical criteria
- Stable carvedilol treatment of at least 6.25 mg/day for at least one month
- No hepatocellular carcinoma outside one nodule ≤ 3 cm or up to 3 nodules on recent imaging
You will not qualify if you...
- Serum total bilirubin greater than 50 µmol/L
- Prothrombin ratio less than 50%
- Transaminases more than 5 times upper limit of normal
- Need for paracentesis for ascites in last 6 months
- Expected follow-up less than 3 months
- Hypersensitivity to study drug or excipients
- History of lactic acidosis or diabetic emergencies
- Conditions causing acute kidney injury or hypoxia recently
- Known allergies to contrast agents, lidocaine, or certain antibiotics
- Alcohol use above specified limits or abstinent less than 6 months
- Biliary cirrhosis or certain liver cancers
- Extra-hepatic cancer without remission
- Severe chronic kidney disease
- Recent or ongoing treatment with metformin or statins
- Recent antiviral treatments for hepatitis B or C
- Complete portal vein thrombosis or portal cavernoma
- History of TIPS, liver transplant, or major liver surgery
- Participation in another interventional trial
- Pregnant or breastfeeding women
- Unable to give consent
- HVPG less than 12 mm Hg at screening catheterization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening including hepatic venous pressure gradient measurement
Treatment
Duration - 28 days
Participants receive metformin or placebo pills twice daily for 28 days to evaluate the effect on hepatic venous pressure gradient and other liver-related outcomes.
Baseline visit and follow-up visits during treatment
Follow-up
Duration - Approximately 30 days after treatment start
Participants are monitored for safety and tolerability of the study drug 30 days after starting treatment.
1 follow-up visit (in-person) for safety assessment
Trial Site Locations
Total: 1 location
1
Facility Name: Beaujon hospital
Clichy, France, France, 92110
Actively Recruiting
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Research Team
L
LUCILE MOGA
P
PIERRE EMMANUEL RAUTOU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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