CirrhosisDYNACORD-ADNCT05413083
Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis
An observational study of Cirrhosis and Acute Liver Failure, run by Clinical Hospital Colentina at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Acute Liver Failure, Cardiomyopathies
- How many people
- 70 participants
- Where
- 1 siteRomania
- Study dates
- 6 Jun 2022to 31 Oct 2024
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- proven cirrhosis with acute decompensation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Assessment of Cardiac Function in Acutely Decompensated Cirrhosis
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.
Read the 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:
- To describe changes and evolution of cardiac function in AD of cirrhosis
- To investigate associations between echocardiographic parameters and serum biomarkers
- To investigate the association between ACLF and cardiac dysfunction
- To assess the short-term prognostic impact of cardiac function in AD and ACLF;
- To evaluate the added predictive value of cardiac markers to current scores (CLIF-C).
- Conditions
- Cirrhosis, Acute Liver Failure, Cardiomyopathies
- Medical subject headings
- Fibrosis, Liver Failure, Acute, Cardiomyopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac dysfunction
rate of onset and evolution of systolic/ diastolic dysfunction in acute decompensation
Measured: 90 days
composite outcome
risk of developing ACLF, disease worsening, or death during follow-up
Measured: 90 days
Secondary outcomes (1)
biomarkers
detecting biomarkers predictive for cardiac dysfunction and disease severity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start6 Jun 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Voiosu, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413083
- Sponsor's protocol ID
- DYNACORD-AD
- Acronym
- DYNACORD-AD
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Assessment of Cardiac Function in Acutely Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT05413083
- Acronym / sponsor ID
- DYNACORD-AD / DYNACORD-AD
- Conditions
- Cirrhosis, Acute Liver Failure, Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To describe changes and evolution of cardiac function in AD of cirrhosis
- To investigate associations between echocardiographic parameters and serum biomarkers
- To investigate the association between ACLF and cardiac dysfunction
- To assess the short-term prognostic impact of cardiac function in AD and ACLF;
- To evaluate the added predictive value of cardiac markers to current scores (CLIF-C).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- proven cirrhosis with acute decompensation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac dysfunction
Time frame: 90 days
rate of onset and evolution of systolic/ diastolic dysfunction in acute decompensation
composite outcome
Time frame: 90 days
risk of developing ACLF, disease worsening, or death during follow-up
1 secondary outcome
biomarkers
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Acute Liver Failure, run by Clinical Hospital Colentina at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac dysfunction (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.