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

Changi General Hospital

Status: Enrolling

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

Treatments: Diagnostic Test: liver and spleen stiffness test and laboratory test

Study type: Observational

Funder types: Other

Identifiers

NCT05899309

2021/2815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Liver cirrhosis with metabolic syndrome

Description:

Liver cirrhosis patients with metabolic syndrome on standard treatment

Treatment:

Diagnostic Test: liver and spleen stiffness test and laboratory test

Liver cirrhosis without metabolic syndrome

Description:

Liver cirrhosis patients without metabolic syndrome on standard treatment

Treatment:

Diagnostic Test: liver and spleen stiffness test and laboratory test