Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Events

NCT ID: NCT01433848

Last Updated: 2011-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Brief Summary

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The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of cirrhosis.

These changes are characterized by abnormalities of systolic contraction in patients undergoing physical or pharmacological stress, changes in diastolic function and electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy. Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.

To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic patients, or their relationship with the prognosis of affected patients. Til now, researches are based on strict echocardiographic parameters, not including several modern methods of assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain, can bring new diagnostic and prognostic information, and it is not reported in the literature. Therefore, the aim of this study is to determine the morphological and functional cardiac changes in patients with cirrhosis and their prognostic role by evaluating new echocardiographic parameters of systolic and diastolic readings.

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Child A liver cirrhosis

No interventions assigned to this group

Child B liver cirrhosis

No interventions assigned to this group

Child C liver cirrhosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with cirrhosis of any etiology, diagnosed by clinical criteria and ultrasound and / or liver biopsy, which excluded patients with causes that also may affect cardiac function (hemochromatosis, Wilson disease, amyloidosis).
* Age between 18 and 80 years.
* Signing of written informed consent.

Exclusion Criteria

* History or presence of systemic arterial hypertension (treated or not)
* History or presence of ischemic heart disease and peripheral vascular disease.
* Presence of greater than mild valvular disease.
* Patients who have a different rhythm in the baseline electrocardiogram, other than sinus (atrial fibrillation, atrial flutter, junctional rhythm).
* Presence of severe anemia (Hb \<7 g / dL).
* Presence of shock, hepatic encephalopathy, bacterial infection or bleeding at inclusion or during the previous week.
* History or presence of severe or decompensated lung disease.
* Presence of percutaneous intrahepatic porto-systemic shunt (TIPS).
* Pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State University

OTHER

Sponsor Role lead

Responsible Party

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Angelo Antunes Salgado

Clinical practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angelo A Salgado, Master

Role: PRINCIPAL_INVESTIGATOR

Rio de Janeiro State University

Carlos Terra, PHD

Role: STUDY_CHAIR

Rio de Janeiro State University

Márcia B Castier, PHD

Role: STUDY_CHAIR

Rio de Janeiro State University

Paulo R Benchimol-Barbosa, DSC

Role: STUDY_CHAIR

Rio de Janeiro State University

Camila SS Reis, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade de Estado do Rio de Janeiro

Locations

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Universidade do Estado do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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Salgado AA, Barbosa PRB, Ferreira AG, Reis CASS, Terra C. Prognostic Value of a New Marker of Ventricular Repolarization in Cirrhotic Patients. Arq Bras Cardiol. 2016 Dec;107(6):523-531. doi: 10.5935/abc.20160181.

Reference Type DERIVED
PMID: 28558079 (View on PubMed)

Other Identifiers

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arquivo1

Identifier Type: -

Identifier Source: org_study_id

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