Precision Medicine to Predict the Trajectory of Liver Cirrhosis : Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Liver related events
研究概览
简要总结
Preventing decompensation is a key endpoint in the management of compensate cirrhosis patients. The known factors that increases the risk of decompensation include the presence of clinically significant portal hypertension (CSPH) and the control of primary etiology of cirrhosis. Other factors which may influence the progression of cirrhosis included the presence of metabolic syndrome (diabetes mellitus and obesity), frailty, concomitant medications (statin, non-selective beta-blocker) were not well understood. Investigators aim to perform a pilot, observational study to study various baseline factors in relation to the clinical outcome of cirrhosis patients in a prospective follow up.
详细描述
All patient who fulfilled eligibility criteria will be consented and recruited. The study will last up to 3 years or up to 7 assessment and 7 visits All subjects will be followed every 6 monthly for study outcome from recruitment, biosamples (blood,urine and stool), elastography, quality of life questionnaire and frialty assessment were done at baseline. Completion of Sit to stand , handgrip and 6 minute walking test at baseline and Visit 3.All visits will be follow up on study outcome (liver-related events ,metabolic related outcome and cardiovascular related outcomes.). During decompensation (decrease in liver function ) .Collection of research leftover blood,urine and stool samples if applicable.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology)
- •Consent to participate in the study
排除标准
- •Terminal malignancy. Subjects with prognosis < 3 months.
- •Patient refusal or unable to commit to study follow-up
结局指标
主要结局
Liver related events
时间窗: 3 years
Determine the rate of liver related events with and without metabolic syndrome
次要结局
- Progression of cirrhosis(3 years)
- Cardiovascular events(3 years)
- Baseline cirrhosis features(3 years)