Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis (CIRRHECHO)
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:
- to investigate the mechanisms which lead to cardiac dysfunction;
- to describe new parameters for the early diagnosis of cirrhotic cardiomyopathy;
- to describe the type of ventriculo-arterial interaction;
- the association between biological markers and echo parameters.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Integrated Approach of Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis: Echocardiography, Specific Biomarkers, and Vascular Assessment|
- Subclinical Myocardial Dysfunction [ Time Frame: Baseline ] [ Designated as safety issue: No ]The main objectives are to detect, by new echocardiographic methods, early cardiac dysfunction in cirrhotic patients
- Biomarkers [ Time Frame: Baseline ] [ Designated as safety issue: No ]To correlate the severity of hepatic disease with different parameters of cardiac dysfunction and biological markers
- Vascular function [ Time Frame: Baseline ] [ Designated as safety issue: No ]To define the type of ventriculo-arterial interaction in these patients.
Biospecimen Retention: Samples Without DNA
- NTproBNP, troponin I;
- myocardial fibrosis (β cross laps and procollagen type-1 amino terminal);
- markers of inflammation (PCR-hs, IL1, IL6, IL 10, TNFα);
- oxidative stress: carbonyl in plasmatic proteins, and the antioxidant capacity of plasma
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Study will include 100 cirrhotic patients, divided in 2 subgroups: 50 with alcoholic cirrhosis, and 50 with viral cirrhosis
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|Contact: Dragos Vinereanu, Professor, PhDemail@example.com|
|Contact: Roxana Cristina Rimbas, MD, PhDfirstname.lastname@example.org|
|University Emergency Hospital||Recruiting|
|Bucharest, Romania, 050098|
|Contact: Dragos Vinereanu, MD, PhD, Professor +40213180576 email@example.com|
|Contact: Roxana Cristina Rimbas, MD, PhD +40740424541 firstname.lastname@example.org|
|Principal Investigator: Dragos Vinereanu, MD, PhD, Professor|
|Sub-Investigator: Roxana Cristina Rimbas, MD, PhD|
|Sub-Investigator: Mihai Rimbas, MD, PhD, Assistent Professor|