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

Recruiting

• Conditions: Spleen; Fibrosis; Liver Cirrhosis; Metabolic Syndrome; Frailty
• Interventions: Diagnostic Test: liver and spleen stiffness test and laboratory test

• Registration Number: NCT05899309
• Lead Sponsor: Changi General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-05-23
• Study First Submitted: 2023-05-24
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-08
• Last Update Submitted: 2023-06-08
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Primary Completion: 2023-12-12
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver cirrhosis with metabolic syndrome	liver and spleen stiffness test and laboratory test	Liver cirrhosis patients with metabolic syndrome on standard treatment
Liver cirrhosis without metabolic syndrome	liver and spleen stiffness test and laboratory test	Liver cirrhosis patients without metabolic syndrome on standard treatment

Primary Outcome Measures

Name	Time	Method
Liver related events	3 years	Determine the rate of liver related events with and without metabolic syndrome

Secondary Outcome Measures

Name	Time	Method
Progression of cirrhosis	3 years	To determine the proportion of patients with cirrhosis progression (stage as defined by D' Amico method).
Cardiovascular events	3 years	Determine the rate of cardiovascular events with and without metabolic syndrome
Baseline cirrhosis features	3 years	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

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore