Cirrhosis Clinical Trial
— CIRRHECHOOfficial title:
An Integrated Approach of Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis: Echocardiography, Specific Biomarkers, and Vascular Assessment
The prevalence of hepatic cirrhosis in Romania is very high, with a 10-year mortality of
34-66%. Upward trend of mortality is observed. It is known that cirrhosis is associated with
cardiac abnormalities. These can induce several complications of cirrhosis, and increase
postoperative mortality. Therefore, it is a major public health issue and research in this
field should be a priority.
Few studies evaluated the cardiac function in cirrhotic patients, using only conventional
echocardiography. However, this allows only the late diagnosis of cardiac dysfunction, which
might be already irreversible. Consequently, description of new parameters, which could
detect early dysfunction, becomes essential. There is no study designed to estimate
intrinsic myocardial properties in cirrhosis. New methods (Tissue Doppler and
Speckle-tracking echocardiography) could be essential to detect early cardiac dysfunction.
The exact role of biological markers in the diagnosis of cardiac dysfunction remains to be
clarified. Impaired cardiac function coupled with augmented vascular function could be the
model for cirrhotic patients. This type of ventriculo-arterial interaction has never been
described.
The main objectives of our project are:
1. to investigate the mechanisms which lead to cardiac dysfunction;
2. to describe new parameters for the early diagnosis of cirrhotic cardiomyopathy;
3. to describe the type of ventriculo-arterial interaction;
4. the association between biological markers and echo parameters.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with certified diagnosis of hepatic cirrhosis; - Age over 18 years; - Informed consent signed; - Sinus rhythm; - Ejection fraction > 50% Exclusion Criteria: - Any history of cardiovascular disease/active cardiovascular treatment(ßblockers used for prevention of the variceal hemorrhage will be stopped 24h before the evaluation); - Diabetes mellitus; - Chronic diseases/neoplasia with estimated survival time under 6 months; - Pulmonary diseases that could affect cardiac function; - Other etiology of cirrhosis that could affect cardiac function: Wilson disease, hemochromatosis, glycogen storage diseases; - Encephalopathy over grade 2/ascitis without medical control; - Inappropriate quality of echocardiographic images. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Romania | University Emergency Hospital | Bucharest |
Lead Sponsor | Collaborator |
---|---|
Carol Davila University of Medicine and Pharmacy |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Vascular function | To define the type of ventriculo-arterial interaction in these patients. | Baseline | No |
Primary | Subclinical Myocardial Dysfunction | The main objectives are to detect, by new echocardiographic methods, early cardiac dysfunction in cirrhotic patients | Baseline | No |
Secondary | Biomarkers | To correlate the severity of hepatic disease with different parameters of cardiac dysfunction and biological markers | Baseline | No |
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