Actively Recruiting
Comparing N-terminal-proB-type Natriuretic Peptide with Other Diagnostic Criteria in Discriminating Heart Failure-associated from Non-heart Failure-associated Pleural Effusions
Led by Chinese University of Hong Kong · Updated on 2024-11-13
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
R
Roche Diagnostics GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well the levels of a substance called N-terminal-proB-type-natriuretic-peptide (NTproBNP) in pleural fluid can identify pleural effusions caused by heart failure (HF). This observational study compares NTproBNP with other standard biochemical tests to see which better distinguishes heart failure-related pleural effusions from those caused by other conditions such as infections, malignancies, or fluid overload. The study is conducted by the Chinese University of Hong Kong and follows patient outcomes for up to three months to confirm the cause of pleural effusion. The study involves patients with pleural effusion who require thoracentesis to analyze the pleural fluid. Two groups are observed: those with pleural effusion due to heart failure and those with effusions from other causes. Researchers will measure pleural fluid levels of NTproBNP, albumin, protein, and lactate dehydrogenase (LDH). Heart failure diagnosis will be confirmed based on clinical features, serum NTproBNP, and echocardiogram results. No treatments are assigned, as this is an observational study. Participants will undergo pleural fluid sampling and clinical assessments including echocardiograms. Researchers will track biochemical markers and clinical factors such as comorbidities and nutritional status over 24 months. They will analyze how well NTproBNP levels correlate with heart failure diagnosis and patient prognosis. The main outcome is comparing the diagnostic accuracy of NTproBNP to other biochemical criteria for identifying heart failure-related pleural effusions. The study does not affect patient care and includes follow-up to monitor outcomes.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients hospitalized for heart failure and pleural effusion
- Pleural tapping indicated for pleural fluid analysis
- Aged 18 years old or above
You will not qualify if you...
- 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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants undergo pleural fluid analysis and clinical assessments to distinguish heart failure-associated pleural effusions from others.
1 visit for pleural fluid collection and clinical assessment
Duration - Up to 3 months
Participants are followed up for up to 3 months to confirm diagnosis and outcomes without affecting clinical management.
Follow-up assessments during routine care
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, New Territories, Hong Kong, 0000
Actively Recruiting
Research Team
C
Christopher Chan, MBChB
K
Ken KP Chan, MBChB
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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