Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis

Cirrhosis Clinical Trial

— DYNACORD-AD  

Official title:

Dynamic Assessment of Cardiac Function in Acutely Decompensated Cirrhosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05413083
• Other study ID #: DYNACORD-AD
• Status: Active, not recruiting
• Start date: June 6, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2024
• Source: Clinical Hospital Colentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Liver Failure
• Cardiomyopathies
• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Failure
• Liver Failure, Acute

Locations

Country	Name	City	State
Romania	Spitalul clinic Colentina	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Colentina

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac dysfunction	rate of onset and evolution of systolic/ diastolic dysfunction in acute decompensation	90 days
Primary	composite outcome	risk of developing ACLF, disease worsening, or death during follow-up	90 days
Secondary	biomarkers	detecting biomarkers predictive for cardiac dysfunction and disease severity	30 days