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

NCT01150916 | Completed

• 1 other identifier: CapPesq0074/10
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure; Liver Cirrhosis; Ascites; Carcinomatosis

Keywords

natriuretic peptide; heart failure; ascites; liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Heart failure

ACTIVE COMPARATOR

Patients must fulfill Framingham and/or Boston criteria for heart failure and have systolic or diastolic disfunction in rest echocardiography.

Procedure: BNP, SAAG, ascites total protein, echocardiography

Liver Cirrhosis

ACTIVE COMPARATOR

Patients must have a biopsy proven diagnosis of liver cirrhosis or the diagnosis established on clinical basis in cases of known etiology of liver disease, peripheral signs of chronic liver disease, esophageal varices at endoscopy and an imaging method with evidence of cirrhosis.

Procedure: BNP, SAAG, ascites total protein, echocardiography

Other causes of ascites

ACTIVE COMPARATOR

Patients must fulfill stringent diagnostic criteria for the cause of ascites, by clinical criteria, laboratory and imaging tests and histology when appropriate.

Procedure: BNP, SAAG, ascites total protein, echocardiography

Concurrent heart failure and cirrhosis

ACTIVE COMPARATOR

Patients must fulfill the aforementioned criteria for both conditions.

Procedure: BNP, SAAG, ascites total protein, echocardiography

Interventions

BNP, SAAG, ascites total protein, echocardiography PROCEDURE

diagnostic tests

Also known as: BNP kit ADVIA Centaur BNP Siemens Inc, San Diego, CA, USA

Concurrent heart failure and cirrhosis; Heart failure; Liver Cirrhosis; Other causes of ascites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Sao Paulo General Hospital: collaborator

Study Sites (2)

Federal University of Espirito Santo

Vitória, Espírito Santo, 29045-402, Brazil

Location

Hospital das Clinicas. University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• Farias AQ, Silvestre OM, Garcia-Tsao G, da Costa Seguro LF, de Campos Mazo DF, Bacal F, Andrade JL, Goncalves LL, Strunz C, Ramos DS, Polli D, Pugliese V, Rodrigues AC, Furtado MS, Carrilho FJ, D'Albuquerque LA. Serum B-type natriuretic peptide in the initial workup of patients with new onset ascites: a diagnostic accuracy study. Hepatology. 2014 Mar;59(3):1043-51. doi: 10.1002/hep.26643. Epub 2014 Jan 13.

  PMID: 23907731 DERIVED

MeSH Terms

Conditions

Heart Failure; Liver Cirrhosis; Ascites; Carcinoma

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Alberto Q. Farias, MD, PhD

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. P.h.D.

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 28, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

BR (2)