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NCT05413083 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 6, 2022
Est. completion date March 31, 2024

Study information
Verified date July 2023
Source Clinical Hospital Colentina
Contact n/a
Is FDA regulated No
Health authority
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 March 31, 2024
Est. primary completion date October 31, 2023
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

Study Design

Related Conditions & MeSH terms

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
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