Trial Information

B-type Natriuretic Peptide in the Diagnosis of Heart Failure Related Ascites

Diagnostic criteria for the cause of ascites - two independent cardiologists and two
hepatologists will interview and examine the enrolled patients and review the clinical
records, laboratory and imaging findings to adjudicate the correct final cause of the
ascites. They will have access to all exams that patients undergo, including results of
biopsies, laboratory tests, chest radiography, Doppler ultrasound, computerized tomography,
magnetic resonance imaging, echocardiography and cardiac catheterism. Liver cirrhosis
diagnosis will be biopsy proven or established on clinical basis in patients with known
etiology of liver disease, peripheral signs of chronic liver disease, esophageal varices at
endoscopy and a compatible imaging method. Heart failure will be diagnosed in patients
fulfilling Framingham and/or Boston criteria and by rest echocardiography. Other causes of
ascites will be diagnosed by appropriate laboratory and imaging tests and by histology when
appropriate.

SAAG, ascitic fluid protein concentration and type-B Natriuretic Peptide - will be assessed
in all patients. BNP measurements will be carried out according to the instructions of the
manufacturer in fresh samples (ADVIA Centaur BNP Siemens Inc, San Diego, CA, USA). This
assay is a fully automated two-site sandwich immunoassay based on chemiluminescent
technology, standardized with synthetic purified protein preparation of human BNP (aminoacid
77 to 108), for quantitative BNP within the range of <2.0 to 5,000 pg/ml. The BNP assay is
reliable in presence of increased values of several biochemical parameters usually found in
patients with decompensated cirrhosis. No interference in measurement has been reported from
urea up to 200 mg/dL, creatinine up to 2.5 mg/dL, unconjugated bilirubin up to 25 mg/dL,
conjugated bilirubin up to 25 mg/dL, triglycerides up to 800 mg/dL, cholesterol up to 1000
mg/dL and from commonly used pharmaceutical drugs. For testing in whole blood, a 4 ml
sample will be collected in an EDTA containing tube. A 10 ml of ascitic fluid will be
collected at the same time by paracentesis before infusion of albumin or volume overload.
Laboratory staff will be unaware of both the clinical diagnosis and routine laboratory
results.

Echocardiography - will performed at rest in all patients for assessing the following
parameters: ejection fraction, left atrium diameter, systolic and diastolic left ventricle
diameter and diastolic dysfunction.

Base-line demographical,past medical history and laboratory test results of all patients
will be recorded.