Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis

Active, not recruiting

• Conditions: Cirrhosis; Cardiomyopathies; Acute Liver Failure

• Registration Number: NCT05413083
• Lead Sponsor: Clinical Hospital Colentina

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:

1. To describe changes and evolution of cardiac function in AD of cirrhosis

2. To investigate associations between echocardiographic parameters and serum biomarkers

3. To investigate the association between ACLF and cardiac dysfunction

4. To assess the short-term prognostic impact of cardiac function in AD and ACLF;

5. To evaluate the added predictive value of cardiac markers to current scores (CLIF-C).

Study Timeline

• Study Start: 2022-06-06
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-08-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiac dysfunction	90 days	rate of onset and evolution of systolic/ diastolic dysfunction in acute decompensation
composite outcome	90 days	risk of developing ACLF, disease worsening, or death during follow-up

Secondary Outcome Measures

Name	Time	Method
biomarkers	30 days	detecting biomarkers predictive for cardiac dysfunction and disease severity

Trial Locations

Locations (1)

Spitalul clinic Colentina; 🇷🇴 Bucharest, Romania