Comparing the Diagnostic Sensitivity and Specificity of Pleural Fluid N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP) and Other Biochemical Gradient Criteria in Distinguishing Heart Failure and Non-heart Failure Related Pleural Effusions (CENTRE Study)

NCT05797649 | Recruiting

• 1 other identifier: NTProBNPPleuralEffusion1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

pleural fluid; heart failure; malignancy; cancer; echocardiography; infection; tuberculosis; respiratory medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To measure the PF NTproBNP level in patients with pleural effusion of various aetiologies

  24 months

• 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

  24 months

• To correlate the PF NTproBNP levels with the echocardiographic features and prognosis of patients with heart failure

  24 months

Study Arms (2)

Heart Failure-Associated Pleural Effusion

Patients with pleural effusion with an underlying aetiology of heart failure

Control group

Patients with pleural effusion due to exudative, or non-fluid overload causes

Eligibility Criteria

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

Study Population

Patients who are admitted to the Department of Medicine \& Therapeutics, Prince of Wales Hospital (PWH) who fulfil the inclusion and exclusion criteria

You may qualify if:

• Patients hospitalized for heart failure and pleural effusion
• Pleural tapping indicated for pleural fluid analysis.
• Aged 18 years old or above

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, New Territories, 0000, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pleural Fluid and Blood

MeSH Terms

Conditions

Pleural Effusion; Heart Failure; Neoplasms; Edema; Hypoalbuminemia; Renal Insufficiency; Fibrosis; Infections; Tuberculosis

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Central Study Contacts

Christopher Chan, MBChB

CONTACT

35053396; christopherchan@cuhk.edu.hk

Ken KP Chan, MBChB

CONTACT

35053396; chankapang@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Tutor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 4, 2023
• Study Start: July 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)