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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Angelo Antunes Salgado, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01433848
First received: August 9, 2011
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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.


Condition
Liver Cirrhosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Adverse Events

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]

    Identify the occurrence of adverse events as defined as:

    1. 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.
    2. either upper or lower gastrointestinal bleeding, characterized by hematemesis (vomiting of blood or coffee-ground like material) and/or melena (black, tarry stools).
    3. spontaneous bacterial peritonitis, characterized by as an ascitic fluid infection without an evident intraabdominal surgically-treatable source.
    4. liver transplant.


Estimated Enrollment: 100
Study Start Date: June 2011
Groups/Cohorts
Child A liver cirrhosis
Child B liver cirrhosis
Child C liver cirrhosis

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433848

Locations
Brazil
Universidade do Estado do Rio de Janeiro
Rio de Janeiro, RJ, Brazil, 20551030
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Angelo Antunes Salgado, Clinical practitioner, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01433848     History of Changes
Other Study ID Numbers: arquivo1
Study First Received: August 9, 2011
Last Updated: September 13, 2011
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 16, 2014