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

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20551030
      • Universidade do Estado do Rio de Janeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Will be selected patients with cirrhosis (diagnosed by clinical criteria and ultrasound and / or liver biopsy) at different evolutionary stages os disease in the hepatology's service at the University Hospital Pedro Ernesto.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Child A liver cirrhosis
Child B liver cirrhosis
Child C liver cirrhosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events as defined as composite of death due to liver failure, gastrointestinal bleeding, spontaneous bacterial peritonitis or need to conduct liver transplant in patients with liver cirrhosis.	Identify the occurrence of adverse events as defined as: death due to liver failure, characterized by development of severe liver injury with impaired synthetic function and encephalopathy in a person who previously had well-compensated liver disease.; either upper or lower gastrointestinal bleeding, characterized by hematemesis (vomiting of blood or coffee-ground like material) and/or melena (black, tarry stools).; spontaneous bacterial peritonitis, characterized by as an ascitic fluid infection without an evident intraabdominal surgically-treatable source.; liver transplant.	12 months follow-up

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Investigators: Principal Investigator: Angelo A Salgado, Master, Rio de Janeiro State University; Study Chair: Carlos Terra, PHD, Rio de Janeiro State University; Study Chair: Márcia B Castier, PHD, Rio de Janeiro State University; Study Chair: Paulo R Benchimol-Barbosa, DSC, Rio de Janeiro State University; Principal Investigator: Camila SS Reis, MD, Universidade de Estado do Rio de Janeiro

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (Estimate): September 14, 2011

Study Record Updates

• Last Update Posted (Estimate): September 14, 2011
• Last Update Submitted That Met QC Criteria: September 13, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: arquivo1