Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis

NCT01713478 | Completed

• 2 other identifiers: CIRRHECHOCIRRMYODYSFUNCTION
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.to investigate the mechanisms which lead to cardiac dysfunction;
2. 2.to describe new parameters for the early diagnosis of cirrhotic cardiomyopathy;
3. 3.to describe the type of ventriculo-arterial interaction;
4. 4.the association between biological markers and echo parameters.

Conditions

Cirrhosis; Cardiomyopathy

Keywords

hepatic cirrhosis; subclinical myocardial dysfunction; echocardiography; specific biomarkers; vascular assessment

Outcome Measures

Primary Outcomes (1)

• Subclinical Myocardial Dysfunction

  The main objectives are to detect, by new echocardiographic methods, early cardiac dysfunction in cirrhotic patients

  Baseline

Secondary Outcomes (1)

• Biomarkers

  Baseline

Other Outcomes (1)

• Vascular function

  Baseline

Study Arms (2)

cirrhotic patients

EXPERIMENTAL

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

normal controls

ACTIVE COMPARATOR

50 normals subjects with the same procedures as cirrhotic patients: echocardiography, ECG, biomarkers

Other: echocardiography

Interventions

echocardiography OTHER

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

Also known as: biomarkers

cirrhotic patients; normal controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with certified diagnosis of hepatic cirrhosis;
• Age over 18 years;
• Informed consent signed;
• Sinus rhythm;
• Ejection fraction \> 50%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

University Emergency Hospital

Bucharest, 050098, Romania

Location

MeSH Terms

Conditions

Fibrosis; Cardiomyopathies; Liver Cirrhosis

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Dragos Vinereanu, Professor

  University of Medicine and Pharmacy Carol Davila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, FESC

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 24, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

RO (1)