Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Events
|ClinicalTrials.gov Identifier: NCT01433848|
Recruitment Status : Unknown
Verified September 2011 by Angelo Antunes Salgado, Rio de Janeiro State University.
Recruitment status was: Enrolling by invitation
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Adverse Events|
|Study Start Date :||June 2011|
|Child A liver cirrhosis|
|Child B liver cirrhosis|
|Child C liver cirrhosis|
- 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:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433848
|Universidade do Estado do Rio de Janeiro|
|Rio de Janeiro, RJ, Brazil, 20551030|
|Principal Investigator:||Angelo A Salgado, Master||Rio de Janeiro State University|
|Study Chair:||Carlos Terra, PHD||Rio de Janeiro State University|
|Study Chair:||Márcia B Castier, PHD||Rio de Janeiro State University|
|Study Chair:||Paulo R Benchimol-Barbosa, DSC||Rio de Janeiro State University|
|Principal Investigator:||Camila SS Reis, MD||Universidade de Estado do Rio de Janeiro|