German SLD-Registry Characterization of Patients With Steatotic Liver Disease (SLD) in Germany - Phase 1 (Observation of the Natural Course)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,681
- 试验地点
- 28
- 主要终点
- Activity of metabolic dysfunction-associated steatohepatitis (MASH)
研究概览
简要总结
Characterization of patients with steatotic liver disease (SLD)
The German SLD-Registry (Deutsches SLD-Register) a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Leberstiftungs-GmbH Deutschland.
The German NAFLD-Registry is financially supported by: Advanz Pharma Specialty Medicine Deutschland GmbH und Gilead Sciences GmbH (Grant to German Livber Foundation) sowie Novo Nordisk Pharma GmbH (directly via Leberstiftungs-GmbH).
详细描述
The following data can be documented:
- physical examination and vital parameters (e.g. age, weight)
- comorbidities (e.g. diabetes mellitus, cardiovascular disease)
- comedication (treatment of comorbidities related to SLD)
- laboratory values (e.g. liver function tests, creatinine)
- genetic variants (e.g. PNPLA3)
- liver diagnostics (e.g. histological findings, sonographic findings)
- lifestyle (alcohol consumption, physical activity)
- health related quality of life (SF-36 questionnaire)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •diagnosed SLD based on the following criteria:
- •typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional)
- •Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography
- •Evaluation of metabolic syndrome
- •credible assessment of alcohol consumption
- •written informed consent
排除标准
- •patients with other hepatologic diseases (chronically viral, metabolic, autoimmune origin
- •patients receiving hepatotoxic medications over a longer period (e.g. methotrexate, amiodarone, longterm NSAR intake)
- •malignant disease with a life expectancy <12 months
- •participation in clinical interventional/pivotal studies
- •inability to provide written informed consent
结局指标
主要结局
Activity of metabolic dysfunction-associated steatohepatitis (MASH)
时间窗: through study completion, an average of 1 year
Activity is measured via histology (NAFLD activity score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8.)
Progression of liver fibrosis
时间窗: through study completion, an average of 1 year
Fibrosis stage is measured by elastography (elastometry kPa value).
Cardiovascular events
时间窗: through study completion, an average of 1 year
The onset of the clinical outcome cardiovascular events (yes/no)
Tumor diseases
时间窗: through study completion, an average of 1 year
The onset of the clinical outcome tumor diseases (yes/no)
次要结局
未报告次要终点