Subclinical Myocardial Dysfunction in Patients With Hepatic Cirrhosis (CIRRHECHO)
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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:
- 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.
| 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 |
- 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
Specific biomarkers:
- 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
| 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
|
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 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.
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| Contact: Dragos Vinereanu, Professor, PhD | +40722670013 | vinereanu@gmail.com |
| Contact: Roxana Cristina Rimbas, MD, PhD | +40740424541 | roxanasisu@gmail.com |
| 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 | |
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 May 16, 2013