Clinical trial NCT01433848: Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Events
Official title: Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Adverse Events
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade do Estado do Rio de Janeiro
state: RJ
Study officials:
affiliation: Rio de Janeiro State University
name: Angelo A Salgado, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Rio de Janeiro State University
name: Carlos Terra, PHD
role: STUDY_CHAIR
affiliation: Rio de Janeiro State University
name: Márcia B Castier, PHD
role: STUDY_CHAIR
affiliation: Rio de Janeiro State University
name: Paulo R Benchimol-Barbosa, DSC
role: STUDY_CHAIR
affiliation: Universidade de Estado do Rio de Janeiro
name: Camila SS Reis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.