NCT05899309

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis
• Metabolic Syndrome
• Spleen; Fibrosis
• Frailty

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	liver and spleen stiffness test and laboratory test	Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)

Timeline

• Start date: 2022-05-23
• Primary completion: 2023-12-12
• Completion: 2024-09-01
• First posted: 2023-06-12
• Last updated: 2023-06-12

Locations

1 site across 1 country: Singapore