NCT05413083

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

June 7, 2022

Last Update Submit

June 3, 2024

Conditions

CirrhosisAcute Liver FailureCardiomyopathies

Outcome Measures

Primary Outcomes (2)

  • cardiac dysfunction

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

    90 days

  • composite outcome

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

    90 days

Secondary Outcomes (1)

  • biomarkers

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All cirrhotic patients admitted for acute decompensated cirrhosis will be screened, regardless of gender, etiology of liver disease, and age (if above 18 years).

You may qualify if:

  • proven cirrhosis with acute decompensation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spitalul clinic Colentina

Bucharest, 020125, Romania

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

centrifuged serum

MeSH Terms

Conditions

FibrosisLiver Failure, AcuteCardiomyopathies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 9, 2022

Study Start

June 6, 2022

Primary Completion

August 31, 2024

Study Completion

October 31, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations

RO(1)