Liver CirrhosisNCT04969055
Prevalence, Clinical Features and Risk Factors of Cirrhotic Cardiomyopathy Assessed by Two-dimensional Speckle Tracking Imaging
An observational study of Liver Cirrhosis and Cirrhotic Cardiomyopathy, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The purpose of this study is to assess the prevalence of cirrhotic cardiomyopathy in patients with cirrhosis, and to analyze the correlation between the severity of cirrhosis and cardiac dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Cirrhotic Cardiomyopathy
- What is being tested?
- Not
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Jul 2022
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: From December 1, 2020 to December 31, 2021, The clear diagnosis of cirrhosis in patients caused by various reasons who have come to our hospital for digestive medicine.
Who may be able to join
- The clear diagnosis of cirrhosis in patients caused by various reasons
Who cannot join
- History of cardiovascular disease
- Diabetes
- High blood pressure
- Hepatocellular carcinoma (HCC) or other malignant tumors
- Patients with the chronic obstructive pulmonary disease
- Thyroid diseases
Show all 11Show fewer
- Severe infection in the last 2 weeks
- History of liver transplantation and/or TIPS surgery
- Presence of stage 3 or above chronic kidney disease or acute chronic kidney disease
- Pregnant women
- Did not sign the informed consent form and refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the prevalence of cirrhotic cardiomyopathy in patients with cirrhosis, and to analyze the correlation between the severity of cirrhosis and cardiac dysfunction. To investigate the risk factors for cirrhotic cardiomyopathy, and raise clinicians' awareness of cirrhotic cardiomyopathy, early assessment and intervention to improve long-term outcomes in patients with cirrhosis.
Read the detailed description
Liver cirrhosis is the terminal stage of the development of chronic liver disease caused by various reasons, and it is often accompanied by multiple complications. Late cirrhosis is often accompanied by obvious changes in liver and systemic hemodynamics. Patients with liver cirrhosis are in a highly dynamic cycle Status: lower arterial blood pressure, increased heart rate, increased cardiac output, peripheral vascular resistance, which often lead to changes in myocardial structure and function, called cirrhotic cardiomyopathy. Cirrhotic cardiomyopathy (CCM) is defined as cardiac dysfunction in patients with end-stage liver disease in the absence of prior heart disease. The true burden of CCM among patients with ESLD is currently unknown. Prior studies evaluated CCM prevalence and estimated it to be approximately 50%, however, this estimate was based on the old criteria. In 2020, the Cirrhotic Cardiomyopathy Association updated the diagnostic criteria for cirrhotic cardiomyopathy. At present, the true prevalence of cirrhotic cardiomyopathy still needs to be reassessed. In addition, studies on the risk factors for cirrhotic cardiomyopathy are rare. Based on the above research background, carry out this research.
- Conditions
- Liver Cirrhosis, Cirrhotic Cardiomyopathy
- Being tested
- Not
- Keywords
- Cirrhosis; cardiac dysfunction;Cardiac Imaging
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NotOther
Not
| Study group | Role | What they receive |
|---|---|---|
| patients with liver cirrhosis | cirrhosis based on either clinical/radiological parameters or liver histology Receives: Other: Not | |
| control group | Healthy ubjects without known heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
cirrhotic cardiomyopathy
Different levels of left ventricular diastolic dysfunction in patients with liver cirrhosis
Measured: Within 48 hours after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Nov 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YanJing Gao, PhD.MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969055
- Sponsor's protocol ID
- 2020-qilu
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu H, Zhang Y, Gao Y. Prevalence and risk factors for cirrhotic cardiomyopathy: a prospective cross-sectional study. Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):469-475. doi: 10.1097/MEG.0000000000002716. Epub 2024 Feb 16.
PubMed 38407871
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Clinical Features and Risk Factors of Cirrhotic Cardiomyopathy Assessed by Two-dimensional Speckle Tracking Imaging
- ClinicalTrials.gov ID
- NCT04969055
- Acronym / sponsor ID
- 2020-qilu
- Conditions
- Liver Cirrhosis, Cirrhotic Cardiomyopathy
- Keywords
- Cirrhosis; cardiac dysfunction;Cardiac Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 20 Jul 2021 (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.
The purpose of this study is to assess the prevalence of cirrhotic cardiomyopathy in patients with cirrhosis, and to analyze the correlation between the severity of cirrhosis and cardiac dysfunction. To investigate the risk factors for cirrhotic cardiomyopathy, and raise clinicians' awareness of cirrhotic cardiomyopathy, early assessment and intervention to improve long-term outcomes in patients with cirrhosis.
Detailed description
Liver cirrhosis is the terminal stage of the development of chronic liver disease caused by various reasons, and it is often accompanied by multiple complications. Late cirrhosis is often accompanied by obvious changes in liver and systemic hemodynamics. Patients with liver cirrhosis are in a highly dynamic cycle Status: lower arterial blood pressure, increased heart rate, increased cardiac output, peripheral vascular resistance, which often lead to changes in myocardial structure and function, called cirrhotic cardiomyopathy. Cirrhotic cardiomyopathy (CCM) is defined as cardiac dysfunction in patients with end-stage liver disease in the absence of prior heart disease. The true burden of CCM among patients with ESLD is currently unknown. Prior studies evaluated CCM prevalence and estimated it to be approximately 50%, however, this estimate was based on the old criteria. In 2020, the Cirrhotic Cardiomyopathy Association updated the diagnostic criteria for cirrhotic cardiomyopathy. At present, the true prevalence of cirrhotic cardiomyopathy still needs to be reassessed. In addition, studies on the risk factors for cirrhotic cardiomyopathy are rare. Based on the above research background, carry out this research.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with liver cirrhosis | – | Other: Notcirrhosis based on either clinical/radiological parameters or liver histology |
| control group | – | –Healthy ubjects without known heart disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From December 1, 2020 to December 31, 2021, The clear diagnosis of cirrhosis in patients caused by various reasons who have come to our hospital for digestive medicine.
Key inclusion criteria (1 listed)
- The clear diagnosis of cirrhosis in patients caused by various reasons
Key exclusion criteria (11 listed)
- History of cardiovascular disease
- Diabetes
- High blood pressure
- Hepatocellular carcinoma (HCC) or other malignant tumors
- Patients with the chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NotNot | Other | patients with liver cirrhosis |
Primary outcome
cirrhotic cardiomyopathy
Time frame: Within 48 hours after hospitalization
Different levels of left ventricular diastolic dysfunction in patients with liver cirrhosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 38407871Xu H, Zhang Y, Gao Y. Prevalence and risk factors for cirrhotic cardiomyopathy: a prospective cross-sectional study. Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):469-475. doi: 10.1097/MEG.0000000000002716. Epub 2024 Feb 16.
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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.
YanJing Gao, PhD.MD principal investigator
Qilu Hospital of Shandong University
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 Liver Cirrhosis and Cirrhotic Cardiomyopathy, run by Qilu Hospital of Shandong University at 1 site in China.
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 11 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 25 Apr 2022. 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 China. 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?
cirrhotic cardiomyopathy (time frame: Within 48 hours after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969055, which also lists 1 linked publication.
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 25 Apr 2022.