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DYNACORD-AD: Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis

Sponsor
Clinical Hospital Colentina (Other)
Overall Status
Recruiting
CT.gov ID
NCT05413083
Collaborator
(none)
120
Enrollment
1
Location
21.8
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective study of cardiocirculatory

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dynamic Assessment of Cardiac Function in Acutely Decompensated Cirrhosis
    Anticipated Study Start Date :
    Jun 6, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Mar 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. cardiac dysfunction [90 days]

      rate of onset and evolution of systolic/ diastolic dysfunction in acute decompensation

    2. composite outcome [90 days]

      risk of developing ACLF, disease worsening, or death during follow-up

    Secondary Outcome Measures

    1. biomarkers [30 days]

      detecting biomarkers predictive for cardiac dysfunction and disease severity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spitalul clinic Colentina Bucharest Romania 020125

    Sponsors and Collaborators

    • Clinical Hospital Colentina

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Voiosu, MD, PhD, Clinical Hospital Colentina
    ClinicalTrials.gov Identifier:
    NCT05413083
    Other Study ID Numbers:
    • DYNACORD-AD
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Liver Failure
    Liver Failure, Acute
    Cardiomyopathies
    Fibrosis

    Study Results

    No Results Posted as of Jun 9, 2022