Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899309
Status:
RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-05-24
Brief Title:
Precision Medicine to Predict the Trajectory of Liver Cirrhosis Prospective Cohort Study
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
Precision Medicine to Predict the Trajectory of Liver Cirrhosis Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bloodurine 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 3All 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 bloodurine and stool samples if applicable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None