Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30,000
- 试验地点
- 4
- 主要终点
- Major-adverse liver outcomes (MALO)
研究概览
简要总结
The rational to conduct the LOVE study builds on the lack of available data on outcomes in steatotic liver disease in well characterized patients over a time frame of several years. At current limited data on liver-specific and overall outcome in patients with MASLD, MetALD and ALD are available. Liver histology is the only accepted surrogate to reasonably likely predict outcomes in patients with non-cirrhotic liver disease and is currently used in regulatory trials. To overcome the limitations of liver biopsy and use validated non-invasive tests (NITs) to predict outcomes, the LOVE study will be conducted based on existing cohort studies in well pheno- and genotyped patients and will inform on the relevant outcomes based on baseline and ongoing biomarker assessment. The overarching goal is to qualify a NIT for patient identification and preventive measures in the regulatory context.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous Informed consent for cohort studies
- •> 18 years of age
- •Diagnosis of SLD (MASLD, MetALD, ALD)
排除标准
- •No consent for previous cohort studies
- •< 18 years of age
- •No Diagnosis of SLD (MASLD, MetALD, ALD)
结局指标
主要结局
Major-adverse liver outcomes (MALO)
时间窗: 5 years follow-up time
Development of cirrhosis. Hepatic decompensation: ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, portal hypertension, varices.
All-cause mortality
时间窗: 5 years follow-up time
Death during the follow-up period due to any cause
次要结局
- Health-related quality of life (HRQL)(5 years)
- Assess prognostic biomarkers and develop a novel tool to integrate them into a digital tool to predict outcomes(5 years)
- Major adverse cardiac events (MACE)(5 years)
- Development of relevant clinical outcomes(5 years)