Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis (CIRRHECHO)

This study is currently recruiting participants.
Verified October 2012 by Carol Davila University of Medicine and Pharmacy
Sponsor:
Information provided by (Responsible Party):
Dragos Vinereanu, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT01713478
First received: October 22, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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
Cirrhosis
Cardiomyopathy

Study Type: Observational
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

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 ] [ Designated as safety issue: No ]
    The main objectives are to detect, by new echocardiographic methods, early cardiac dysfunction in cirrhotic patients


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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

Specific biomarkers:

  1. NTproBNP, troponin I;
  2. myocardial fibrosis (β cross laps and procollagen type-1 amino terminal);
  3. markers of inflammation (PCR-hs, IL1, IL6, IL 10, TNFα);
  4. oxidative stress: carbonyl in plasmatic proteins, and the antioxidant capacity of plasma

Estimated Enrollment: 100
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)
Groups/Cohorts
cirrhotic patients

Study will include 100 cirrhotic patients, divided in 2 subgroups: 50 with alcoholic cirrhosis, and 50 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Study will include 100 cirrhotic patients from gastroenterology department, divided in 2 subgroups: 50 with alcoholic cirrhosis, and 50 with viral cirrhosis, and for comparison 25 normal individuals.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713478

Contacts
Contact: Dragos Vinereanu, Professor, PhD +40722670013 vinereanu@gmail.com
Contact: Roxana Cristina Rimbas, MD, PhD +40740424541 roxanasisu@gmail.com

Locations
Romania
University Emergency Hospital Recruiting
Bucharest, Romania, 050098
Contact: Dragos Vinereanu, MD, PhD, Professor    +40213180576    vinereanu@gmail.com   
Contact: Roxana Cristina Rimbas, MD, PhD    +40740424541    roxanasisu@gmail.com   
Principal Investigator: Dragos Vinereanu, MD, PhD, Professor         
Sub-Investigator: Roxana Cristina Rimbas, MD, PhD         
Sub-Investigator: Mihai Rimbas, MD, PhD, Assistent Professor         
Sponsors and Collaborators
Carol Davila University of Medicine and Pharmacy
  More Information

No publications provided

Responsible Party: Dragos Vinereanu, Professor, MD, PhD, FESC, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT01713478     History of Changes
Other Study ID Numbers: CIRRHECHO, CIRRMYODYSFUNCTION
Study First Received: October 22, 2012
Last Updated: October 26, 2012
Health Authority: Romania: National Authority for Scientific Research

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

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Heart Failure
Cardiomyopathies
Liver Diseases
Digestive System Diseases
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014