Heart Failure Clinical Trial
Official title:
B-type Natriuretic Peptide in the Diagnosis of Heart Failure Related Ascites
The serum albumin ascites gradient (SAAG) is a recommended tool for ascites diagnosis since
values ≥1.1 g/dl are found in nearly 97% of patients with portal hypertension. However, it
mislabels chronic liver disease and heart failure as the cause of ascites. Because type-B
Natriuretic Peptide (BNP) is increased in several body fluids of patients with both systolic
and diastolic dysfunction, it was found to be a useful marker for diagnosing heart failure
and pleural effusion due to heart failure. Nevertheless, to date, the performance of BNP
testing for assessing the etiology of ascites has not been examined. The current prospective
study is aimed at comparing the following strategies for diagnosing heart failure as the
cause of ascites: 1) SAAG plus total protein concentration in ascitic fluid (gold standard);
2) SAAG plus BNP concentration in ascitic fluid; 3) SAAG plus BNP concentration in serum; 4)
serum BNP concentrations.
SAAG, ascitic fluid protein concentration, serum and ascites type-B Natriuretic Peptide and
echocardiography will be performed in all patients. The final diagnosis of the cause of
ascites will be adjudicated by independent physicians, blinded for the results of ascitic
fluid biochemistry and BNP. Patients will be divided into four groups: Heart failure, Liver
cirrhosis, concurrent heart failure and liver cirrhosis (mixed) and other causes of ascites.
Status | Completed |
Enrollment | 278 |
Est. completion date | March 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - more than 18 years old. - must have signed the written informed consent. - ascites of any etiology on clinical and laboratory imaging. - fulfil stringent diagnostic criteria for the cause of the ascites. Exclusion Criteria: - contra-indication for paracentesis (hemodynamic instability, shock, active variceal bleeding etc). - sepsis. - fulminant liver failure. - pregnancy. - history of recent transfusion of blood components and/or derivates or volume expansion. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clinicas. University of São Paulo | Sao Paulo | |
Brazil | Federal University of Espirito Santo | Vitoria | Espirito Santo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diagnostic accuracy of BNP for the diagnosis of ascites due to heart failure | ROC curves of different strategies with and without BNP levels for diagnosing heart failure as the cause of ascites. Sensitivity, specificity, accuracy, predictive values, likelihood ratios. |
6 months | No |
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