Heart FailureNCT01150916
B-type Natriuretic Peptide in the Diagnosis of Heart Failure Related Ascites
A study testing BNP, SAAG, ascites total protein, echocardiography in people with Heart Failure and Liver Cirrhosis, run by University of Sao Paulo at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Liver Cirrhosis, Ascites
- What is being tested?
- BNP, SAAG, ascites total protein, echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital das Clinicas. University of São Paulo
São Paulo, São Paulo, 05403-000
Federal University of Espirito Santo
Vitória, Espírito Santo, 29045-402
About this study
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.
Read the detailed description
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.
- Conditions
- Heart Failure, Liver Cirrhosis, Ascites, Carcinomatosis
- Being tested
- BNP, SAAG, ascites total protein, echocardiography
- Keywords
- natriuretic peptide, heart failure, ascites, liver cirrhosis
- Medical subject headings
- Heart Failure, Liver Cirrhosis, Ascites, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNP, SAAG, ascites total protein, echocardiographyProcedure or surgery
Also called BNP kit ADVIA Centaur BNP Siemens Inc, San Diego, CA, USA
diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Active comparator | Patients must fulfill Framingham and/or Boston criteria for heart failure and have systolic or diastolic disfunction in rest echocardiography. Receives: 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. Receives: 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. Receives: Procedure: BNP, SAAG, ascites total protein, echocardiography |
| Concurrent heart failure and cirrhosis | Active comparator | Patients must fulfill the aforementioned criteria for both conditions. Receives: Procedure: BNP, SAAG, ascites total protein, echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Responsible party
- Principal investigator, Alberto Queiroz Farias, University of Sao Paulo
- Investigators
- Alberto Q. Farias, MD, PhD, Principal investigator, University of Sao Paulo School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150916
- Sponsor's protocol ID
- CapPesq0074/10
- Status last verified
- Dec 2012
- First submitted
- 23 Jun 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23907731
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-type Natriuretic Peptide in the Diagnosis of Heart Failure Related Ascites
- ClinicalTrials.gov ID
- NCT01150916
- Acronym / sponsor ID
- CapPesq0074/10
- Conditions
- Heart Failure, Liver Cirrhosis, Ascites, Carcinomatosis
- Keywords
- natriuretic peptide, heart failure, ascites, liver cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Heart failure | Active comparator | Procedure: BNP, SAAG, ascites total protein, echocardiographyPatients must fulfill Framingham and/or Boston criteria for heart failure and have systolic or diastolic disfunction in rest echocardiography. |
| Liver Cirrhosis | Active comparator | Procedure: BNP, SAAG, ascites total protein, echocardiographyPatients 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. |
| Other causes of ascites | Active comparator | Procedure: BNP, SAAG, ascites total protein, echocardiographyPatients must fulfill stringent diagnostic criteria for the cause of ascites, by clinical criteria, laboratory and imaging tests and histology when appropriate. |
| Concurrent heart failure and cirrhosis | Active comparator | Procedure: BNP, SAAG, ascites total protein, echocardiographyPatients must fulfill the aforementioned criteria for both conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNP, SAAG, ascites total protein, echocardiographyAlso: BNP kit ADVIA Centaur BNP Siemens Inc, San Diego, CA, USAdiagnostic tests | Procedure or surgery | Concurrent heart failure and cirrhosis, Heart failure, Liver Cirrhosis, Other causes of ascites |
Primary outcome
diagnostic accuracy of BNP for the diagnosis of ascites due to heart failure
Time frame: 6 months
* 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- Derived from this study: PubMed 23907731Farias 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Q. Farias, MD, PhD principal investigator
University of Sao Paulo School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BNP, SAAG, ascites total protein, echocardiography in people with Heart Failure and Liver Cirrhosis, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy of BNP for the diagnosis of ascites due to heart failure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.