Precision Medicine to Predict the Trajectory of Liver Cirrhosis: Prospective Cohort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Precision Medicine to Predict the Trajectory of Liver Cirrhosis : Prospective Cohort Study

Conditions
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Liver Cirrhosis, Metabolic Syndrome, Spleen; Fibrosis, Frailty

Intervention / Treatment
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* Diagnostic Test: liver and spleen stiffness test and laboratory test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology) Consent to participate in the study Exclusion Criteria: Terminal malignancy. Subjects with prognosis < 3 months. Patient refusal or unable to commit to study follow-up

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver cirrhosis with metabolic syndrome<br>Liver cirrhosis patients with metabolic syndrome on standard treatment | Diagnostic Test: liver and spleen stiffness test and laboratory test<br>* Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)<br>|
| Liver cirrhosis without metabolic syndrome<br>Liver cirrhosis patients without metabolic syndrome on standard treatment | Diagnostic Test: liver and spleen stiffness test and laboratory test<br>* Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver related events | Determine the rate of liver related events with and without metabolic syndrome | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of cirrhosis | To determine the proportion of patients with cirrhosis progression (stage as defined by D' Amico method). | 3 years | 
| Cardiovascular events | Determine the rate of cardiovascular events with and without metabolic syndrome | 3 years | 
| Baseline cirrhosis features | Baseline differences (clinical, immunological and metabolomic differences) and liver stiffness and spleen stiffness measured using vibration on controlled transient elastography (in kPa) between cirrhosis patients with and without metabolic syndrome | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cirrhosis, Metabolic syndrome, Cardiovascular events