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Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis (CIRRHECHO)

This study has been completed.
Information provided by (Responsible Party):
Dragos Vinereanu, Carol Davila University of Medicine and Pharmacy Identifier:
First received: October 22, 2012
Last updated: February 3, 2015
Last verified: February 2015

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.

Condition Intervention
Other: echocardiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Integrated Approach of Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis: Echocardiography, Specific Biomarkers, and Vascular Assessment

Resource links provided by NLM:

Further study details as provided by Carol Davila University of Medicine and Pharmacy:

Primary Outcome Measures:
  • Subclinical Myocardial Dysfunction [ Time Frame: Baseline ]
    The main objectives are to detect, by new echocardiographic methods, early cardiac dysfunction in cirrhotic patients

Secondary Outcome Measures:
  • Biomarkers [ Time Frame: Baseline ]
    To correlate the severity of hepatic disease with different parameters of cardiac dysfunction and biological markers

Other Outcome Measures:
  • Vascular function [ Time Frame: Baseline ]
    To define the type of ventriculo-arterial interaction in these patients.

Enrollment: 100
Study Start Date: December 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cirrhotic patients

Study will include 50 cirrhotic patients, divided in 2 subgroups: 25 with alcoholic cirrhosis, and 25 with viral cirrhosis

  1. Routine blood samples
  2. Electrocardiogram (12 leads)
  3. Specific biomarkers: proBNP, troponin, myocardial fibrosis (β cross laps and procollagen type-1 amino terminal), and markers of inflammation (PCR-hs, IL1, IL6, IL 10, TNFα); oxidative stress: carbonyl in plasmatic proteins, and the antioxidant capacity of plasma.
  4. Comprehensive Echocardiography
Other: echocardiography
The patients and controls will be investigated by echocardiography, biomarkers, and ECG. After 1 year investigators will assess 1year mortality.
Other Name: biomarkers
Active Comparator: normal controls
50 normals subjects with the same procedures as cirrhotic patients: echocardiography, ECG, biomarkers
Other: echocardiography
The patients and controls will be investigated by echocardiography, biomarkers, and ECG. After 1 year investigators will assess 1year mortality.
Other Name: biomarkers

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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(βblockers 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01713478

University Emergency Hospital
Bucharest, Romania, 050098
Sponsors and Collaborators
Carol Davila University of Medicine and Pharmacy
Principal Investigator: Dragos Vinereanu, Professor University of Medicine and Pharmacy Carol Davila
  More Information

Responsible Party: Dragos Vinereanu, Professor, MD, PhD, FESC, Carol Davila University of Medicine and Pharmacy Identifier: NCT01713478     History of Changes
Other Study ID Numbers: CIRRHECHO
Study First Received: October 22, 2012
Last Updated: February 3, 2015

Keywords provided by Carol Davila University of Medicine and Pharmacy:
hepatic cirrhosis
subclinical myocardial dysfunction
specific biomarkers
vascular assessment

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Heart Diseases
Cardiovascular Diseases processed this record on April 28, 2017