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

R

Rio de Janeiro State University

Status

Unknown

Conditions

Liver Cirrhosis

Study type

Observational

Funder types

Other

Identifiers

NCT01433848
arquivo1

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 3 patient groups

Child A liver cirrhosis
Child B liver cirrhosis
Child C liver cirrhosis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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