Effects of Metformin on hepatic venous pressure gradient in patients with cirrhosis and portal hypertension – A randomized placebo-controlled study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- the hepatic venous pressure gradient (HVPG) after 28 days of treatment
研究概览
简要总结
To evaluate the effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol. Objectif of the ancillary study : To study the effect of metformin on postprandial changes in systemic haemodynamics and HVPG.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Absence of hepatocellular carcinoma outside at least one nodule > 3 cm in diameter, or more than 3 nodules, on ultrasound, CT-scan or MRI performed during the previous 6 months
- •Written informed consent to participate in the study
- •Medical insurance coverage
- •For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception
- •Diagnosis of cirrhosis based on a liver biopsy, or on clinical, biological, endoscopic, and radiological evidence
- •Active cause of cirrhosis, or resolution (alcohol cessation, sustained virological response to direct-acting antiviral treatment for HCV, initiation of nucleoside/nucleotide analog treatment for HBV) for at least 6 months
- •Child-Pugh A or B
- •High likelihood of HVPG ≥ 12 mm Hg based on investigator’s judgement, _confer criteria in the protocole
- •Treatment with carvedilol (≥ 6,25 mg/day) at a stable dose for at least one month
排除标准
- •Serum total bilirubin > 50 µmol/L
- •Prothrombin ratio < 50 %
- •Transaminases > 5 ULN
- •Need for at least one paracentesis for ascites fluid evacuation in the last 6 months
结局指标
主要结局
the hepatic venous pressure gradient (HVPG) after 28 days of treatment
the hepatic venous pressure gradient (HVPG) after 28 days of treatment
Endpoints of the ancillary study: Changes in systemic haemodynamics and HVPG 30 minutes after a meal consisting of two 200 mL bottles of hypercaloric/hyperprotic Fortimel Energy
Endpoints of the ancillary study: Changes in systemic haemodynamics and HVPG 30 minutes after a meal consisting of two 200 mL bottles of hypercaloric/hyperprotic Fortimel Energy
次要结局
未报告次要终点
研究者
Lucile Moga
Scientific
Assistance Publique Hopitaux De Paris