Actively Recruiting

Age: 18Years +
All Genders
ID05797649

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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