Personalized Medicine in HCV Chronic Infection. Endothelial Dysfunction and Subclinical Atheromatosis in Patients With HCV Infection. Characterization and Potential Reversibility With Direct Antiviral Agents.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in Flow mediated dilatation (FMD)
研究概览
简要总结
Hypothesis: In addition to the liver deleterious effects, Chronic Hepatitis C (CHC) can cause changes in other organs highlighting the increased cardiovascular risk (CVR) through accelerated atherosclerosis, whose consequences may persist even after healing infection with new antiviral treatments. This can have major impact on the health system. Obtaining a Sustained Virological Response (SVR) with a free Interferon (IFN) antiviral treatment is probably able to reverse, at least partially, increased vascular risk induced by Hepatitis C virus (HCV) and perhaps ultimately reverse the subclinical atherosclerosis.
Aims: To study the presence of early-subclinical atherosclerotic disease (endothelial dysfunction and subclinical atherosclerosis) in patients with CHC and evaluate the influence of treatment in the short and medium term on the CVR derived. Studying these same issues but in patients with established atherosclerotic disease.
详细描述
Design:
Prospective interventional study.
Patients and methods:
Tracked on a population of 80 patients with CHC (estimated fibrosis F2-F3),
An evaluation of the CVR will be performed by determining biomarkers of endothelial activation and macrophage activation, measuring flow-mediated vasodilation and atherosclerotic damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV infected patients (aged 18-75 yr)
- •Naive or failure to previous treatments
- •Liver fibrosis F2-F3 in Fibroscan/liver biopsy
- •Accept the study and sign the CI
排除标准
- •Known cardiovascular diseases
- •Does not meet the above criteria
- •VIH or other viral coinfection
- •Hepatocarcinoma
- •Pregnancy
结局指标
主要结局
Changes in Flow mediated dilatation (FMD)
时间窗: Basal and 3, 12 and 24 months after the end of treatment
FMD: Vasodilation mediated by ultrasound brachial flow through the rate of increase of brachial artery diameter (d2) as compared to baseline (d1) after a ischemia time (300 mmHg) for 4 minutes (FMD = (d2-d1) / d1 (x 100).
次要结局
- Changes in cIMT (Carotid intima-media thickness)(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in the presence of carotid plaques(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in CD163 serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in HDL serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Adverse events(up to 24 weeks)
- Changes in VCAM-1 serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in E-selectin serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in P-selectin serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in LDL serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Presence of Sustained Viral Response(3, 6 and 12 months after the end of treatment)
- Changes in MCP-1 serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in ICAM-1 serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in galectin-3-binding protein serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in Lp(a) serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in hs-PCR serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in VLDL serum levels(Basal and 3, 12 and 24 months after the end of treatment)
- Changes in HOMA(Basal and 3, 12 and 24 months after the end of treatment)