Liver CirrhosisNCT01433848
Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Events
An observational study of Liver Cirrhosis, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to not given
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Will be selected patients with cirrhosis (diagnosed by clinical criteria and ultrasound and / or liver biopsy) at different evolutionary stages os disease in the hepatology's service at the University Hospital Pedro Ernesto.
Who may be able to join
- Patients with cirrhosis of any etiology, diagnosed by clinical criteria and ultrasound and / or liver biopsy, which excluded patients with causes that also may affect cardiac function (hemochromatosis, Wilson disease, amyloidosis).
- Age between 18 and 80 years.
- Signing of written informed consent.
Who cannot join
- History or presence of systemic arterial hypertension (treated or not)
- History or presence of ischemic heart disease and peripheral vascular disease.
- Presence of greater than mild valvular disease.
- Patients who have a different rhythm in the baseline electrocardiogram, other than sinus (atrial fibrillation, atrial flutter, junctional rhythm).
- Presence of severe anemia (Hb <7 g / dL).
- Presence of shock, hepatic encephalopathy, bacterial infection or bleeding at inclusion or during the previous week.
Show all 9Show fewer
- History or presence of severe or decompensated lung disease.
- Presence of percutaneous intrahepatic porto-systemic shunt (TIPS).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20551030
About this study
Official title: Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Adverse Events
The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of cirrhosis.
These changes are characterized by abnormalities of systolic contraction in patients undergoing physical or pharmacological stress, changes in diastolic function and electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy. Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.
To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic patients, or their relationship with the prognosis of affected patients. Til now, researches are based on strict echocardiographic parameters, not including several modern methods of assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain, can bring new diagnostic and prognostic information, and it is not reported in the literature. Therefore, the aim of this study is to determine the morphological and functional cardiac changes in patients with cirrhosis and their prognostic role by evaluating new echocardiographic parameters of systolic and diastolic readings.
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Child A liver cirrhosis | Not described | |
| Child B liver cirrhosis | Not described | |
| Child C liver cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events as defined as composite of death due to liver failure, gastrointestinal bleeding, spontaneous bacterial peritonitis or need to conduct liver transplant in patients with liver cirrhosis.
Identify the occurrence of adverse events as defined as:
- death due to liver failure, characterized by development of severe liver injury with impaired synthetic function and encephalopathy in a person who previously had well-compensated liver disease.
- either upper or lower gastrointestinal bleeding, characterized by hematemesis (vomiting of blood or coffee-ground like material) and/or melena (black, tarry stools).
- spontaneous bacterial peritonitis, characterized by as an ascitic fluid infection without an evident intraabdominal surgically-treatable source.
- liver transplant.
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startJun 2011
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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Antunes Salgado, Rio de Janeiro State University
- Investigators
- Angelo A Salgado, Master, Principal investigator, Rio de Janeiro State UniversityCarlos Terra, PHD, Study chair, Rio de Janeiro State UniversityMárcia B Castier, PHD, Study chair, Rio de Janeiro State UniversityPaulo R Benchimol-Barbosa, DSC, Study chair, Rio de Janeiro State UniversityCamila SS Reis, MD, Principal investigator, Universidade de Estado do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433848
- Sponsor's protocol ID
- arquivo1
- Status last verified
- Sep 2011
- First submitted
- 9 Aug 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Salgado AA, Barbosa PRB, Ferreira AG, Reis CASS, Terra C. Prognostic Value of a New Marker of Ventricular Repolarization in Cirrhotic Patients. Arq Bras Cardiol. 2016 Dec;107(6):523-531. doi: 10.5935/abc.20160181.
PubMed 28558079
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Adverse Events
- ClinicalTrials.gov ID
- NCT01433848
- Acronym / sponsor ID
- arquivo1
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Jun 2011
- First posted
- 14 Sep 2011 (estimated)
- 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 cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of cirrhosis.
These changes are characterized by abnormalities of systolic contraction in patients undergoing physical or pharmacological stress, changes in diastolic function and electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy. Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.
To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic patients, or their relationship with the prognosis of affected patients. Til now, researches are based on strict echocardiographic parameters, not including several modern methods of assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain, can bring new diagnostic and prognostic information, and it is not reported in the literature. Therefore, the aim of this study is to determine the morphological and functional cardiac changes in patients with cirrhosis and their prognostic role by evaluating new echocardiographic parameters of systolic and diastolic readings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child A liver cirrhosis | – | – |
| Child B liver cirrhosis | – | – |
| Child C liver cirrhosis | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Will be selected patients with cirrhosis (diagnosed by clinical criteria and ultrasound and / or liver biopsy) at different evolutionary stages os disease in the hepatology's service at the University Hospital Pedro Ernesto.
Key inclusion criteria (3 listed)
- Patients with cirrhosis of any etiology, diagnosed by clinical criteria and ultrasound and / or liver biopsy, which excluded patients with causes that also may affect cardiac function (hemochromatosis, Wilson disease, amyloidosis).
- Age between 18 and 80 years.
- Signing of written informed consent.
Key exclusion criteria (9 listed)
- History or presence of systemic arterial hypertension (treated or not)
- History or presence of ischemic heart disease and peripheral vascular disease.
- Presence of greater than mild valvular disease.
- Patients who have a different rhythm in the baseline electrocardiogram, other than sinus (atrial fibrillation, atrial flutter, junctional rhythm).
- Presence of severe anemia (Hb <7 g / dL).
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
Adverse events as defined as composite of death due to liver failure, gastrointestinal bleeding, spontaneous bacterial peritonitis or need to conduct liver transplant in patients with liver cirrhosis.
Time frame: 12 months follow-up
Identify the occurrence of adverse events as defined as: 1. death due to liver failure, characterized by development of severe liver injury with impaired synthetic function and encephalopathy in a person who previously had well-compensated liver disease. 2. either upper or lower gastrointestinal bleeding, characterized by hematemesis (vomiting of blood or coffee-ground like material) and/or melena (black, tarry stools). 3. spontaneous bacterial peritonitis, characterized by as an ascitic fluid infection without an evident intraabdominal surgically-treatable source. 4. liver transplant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
- Derived from this study: PubMed 28558079Salgado AA, Barbosa PRB, Ferreira AG, Reis CASS, Terra C. Prognostic Value of a New Marker of Ventricular Repolarization in Cirrhotic Patients. Arq Bras Cardiol. 2016 Dec;107(6):523-531. doi: 10.5935/abc.20160181.
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Angelo A Salgado, Master principal investigator
Rio de Janeiro State University
Carlos Terra, PHD study chair
Rio de Janeiro State University
Márcia B Castier, PHD study chair
Rio de Janeiro State 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, run by Rio de Janeiro State University at 1 site in Brazil.
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 3 inclusion and 9 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 14 Sep 2011. 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 Brazil. 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?
Adverse events as defined as composite of death due to liver failure, gastrointestinal bleeding, spontaneous bacterial peritonitis or need to conduct liver transplant in patients with liver cirrhosis. (time frame: 12 months follow-up). 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 NCT01433848, 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 14 Sep 2011.