Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis

NCT01713478 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-02-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

echocardiography

The patients and controls will be investigated by echocardiography, biomarkers, and ECG. After 1 year investigators will assess 1year mortality.

Sponsors & Collaborators

  • Carol Davila University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Dragos Vinereanu, Professor · University of Medicine and Pharmacy Carol Davila

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Romania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01713478 on ClinicalTrials.gov