Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis

Heart Failure Clinical Trial

Official title:

Comparing N-terminal-proB-type Natriuretic Peptide With Other Diagnostic Criteria in Discriminating Heart Failure-associated From Non-heart Failure-associated Pleural Effusions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797649
• Other study ID #: NTProBNPPleuralEffusion1
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: October 2023
• Source: Chinese University of Hong Kong
• Contact: Christopher Chan, MBChB
• Phone: 35053396
• Email: christopherchan[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Description:

Objective: To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Hypothesis to be tested: The PF NTproBNP levels are superior to existing methods including Light's criteria, serum/pleural fluid (S/PF) protein gradient, and albumin gradient, in identifying transudates and distinguishing between HF- and non-HF-associated PE.

Design and subjects: A prospective case-control study involving patients with PE requiring thoracentesis, caused by hypervolaemia due to HF, diseases other than HF, and patients with pleural effusion without hypervolaemia. Patient characteristics, PF results and effusion aetiology will be analysed. Patient outcomes will be followed up to 3 months to confirm the aetiology of PE. Clinical management of patients will not be affected.

Study instruments: PF of recruited patients will be analysed for albumin, protein, lactate dehydrogenase (LDH) levels and NTproBNP. The diagnosis of HF will be based on clinical features, serum NTproBNP and echocardiogram.

Main outcome measures: The performance of PF NTproBNP level in identifying HF-associated PE.

Data analysis: The PF NTproBNP level will be compared between effusions of different aetiologies. The optimal pleural fluid NTproBNP level with largest area under the receiver operating characteristic curve in identifying HF-associated PE will be determined. Performance of PF NTproBNP level in identifying HF-associated PE, and other biochemical criteria in identifying transudates will be compared. Echocardiographic findings will be correlated with the PF NTproBNP levels.

Expected results: The diagnostic performance of PF NTproBNP will be significantly better in identifying HF-associated effusion than other biochemical criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalized for heart failure and pleural effusion

• Pleural tapping indicated for pleural fluid analysis.

• Aged 18 years old or above

Exclusion Criteria:

• History of intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space.

• History of surgical decortication or pleurodesis in the ipsilateral pleural space.

• Ipsilateral thoracic or cardiac surgery in the past 3 months.

• Failure to obtain informed consent due to the patient's refusal or cognitive impairment.

Related Conditions & MeSH terms

• Cirrhosis
• Fluid Overload
• Heart Failure
• Hypoalbuminemia
• Infections
• Malignant Neoplasm
• Neoplasms
• Pleural Effusion
• Renal Failure

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong	New Territories

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Roche Diagnostics

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the diagnostic performance of PF NTproBNP level in the diagnosis of HF-associated pleural effusions with other conventional biochemical criteria	Pleural fluid NTproBNP will be measured in patients with pleural effusion of various aetiologies including malignancy, pleural infection, heart failure and other causes of volume overload. The sensitivity and specificity of an elevated pleural fluid NTproBNP level in successfully identifying a pleural effusion due to underlying heart failure will be measured and compared against existing classification criteria for pleural effusion such as Light's Criteria, pleural-serum protein gradient or albumin gradient.	24 months
Secondary	To measure the PF NTproBNP level in patients with pleural effusion of various aetiologies		24 months
Secondary	Correlation of clinical factors that may affect the levels of pleural fluid NTproBNP such as echocardiographic features, presence of comorbidities, nutritional status, serum albumin level, levels of inflammatory markers and presence of infection	Clinical data of patients admitted to the hospital with pleural effusion will be measured and recorded. Statistical analysis will then be performed to evaluate for degree of correlation between the presence or severity of a clinical parameter, echocardiogram results e.g. severe valvular stenosis, or, e.g. presence of medical comorbidities or presence of concomitant infection, and the levels of NTproBNP identified in the patient's pleural fluid detected within same admission.	24 months
Secondary	To correlate the PF NTproBNP levels with the echocardiographic features and prognosis of patients with heart failure		24 months