Dynamic Assessment of Cardiac Function in Acutely Decompensated Cirrhosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- cardiac dysfunction
Study Overview
Brief Summary
This project aims to investigate cardiac function in patients with cirrhosis in the acute setting. Acute decompensation and acute-on-chronic liver failure are major events in the life of a patient as they herald disease progression and negative prognosis. Cardiocirculatory function will be assessed by serial assessments in patients admitted for acute decompensation of cirrhosis.
Detailed Description
In this project we aim to investigate the dynamic role of cardiac function in the short-term evolution of patients with AD of cirrhosis through noninvasive and accessible tests and validate prognostic imaging and serum biomarkers. The main objectives are:
- To describe changes and evolution of cardiac function in AD of cirrhosis
- To investigate associations between echocardiographic parameters and serum biomarkers
- To investigate the association between ACLF and cardiac dysfunction
- To assess the short-term prognostic impact of cardiac function in AD and ACLF;
- To evaluate the added predictive value of cardiac markers to current scores (CLIF-C).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •proven cirrhosis with acute decompensation
Exclusion Criteria
- •screening after > 72 hours from admission
- •previous severe cardiac conditions (e.g. ischemic heart disease, atrial fibrillation, congestive heart failure, ICD)
- •concomitant severe disease (e.g. active neoplasia, severe COPD, etc)
- •lack of informed consent
- •intubated/ comatose patient
Outcomes
Primary Outcomes
cardiac dysfunction
Time Frame: 90 days
rate of onset and evolution of systolic/ diastolic dysfunction in acute decompensation
composite outcome
Time Frame: 90 days
risk of developing ACLF, disease worsening, or death during follow-up
Secondary Outcomes
- biomarkers(30 days)
Investigators
Andrei Voiosu
Principal investigator
Clinical Hospital Colentina