Comprehensive Clinical Prediction Rule for Acute Heart Failure
August 9, 2026 updated by: Kevin HUNG Kei-ching, Chinese University of Hong Kong
Establishing a Comprehensive Clinical Prediction Rule for the Diagnosis of Acute Heart Failure in the Emergency Department
The goal of this prospective observational cohort study is to establish a comprehensive clinical prediction rule integrating clinical characteristics, point-of-care testing (POCT) of NT-proBNP, an 8-point LUS, and a rapid cardiac assessment using bedside echocardiography for diagnosing acute heart failure (AHF) in the emergency department.
A clinical prediction rule with high diagnostic accuracy will minimize delays and misdiagnoses, as well as the potential harm they may cause to patients.
The primary outcome measure is the adjudicated AHF diagnosis.
Secondary outcome measures include ED and discharge diagnosis of the patients.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
560
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Theresa Hui
- Phone Number: +85235051698
- Email: theresahui@cuhk.edu.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Queen Mary Hospital
-
Contact:
- Rex PK Lam, Dr.
- Phone Number: +85239179175
- Email: lampkrex@hku.hk
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Principal Investigator:
- Rex PK Lam, Dr.
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Contact:
- Theresa Hui
- Phone Number: +85235051698
- Email: theresahui@cuhk.edu.hk
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Principal Investigator:
- Kevin KC Hung, Dr.
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Hong Kong, Hong Kong
- Tuen Mun Hospital
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Contact:
- Jeffrey HT Fung, Dr.
- Phone Number: +85224685111
- Email: funght@ha.org.hk
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Principal Investigator:
- Jeffrey HT Fung, Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Adult patients attending the emergency departments of Prince of Wales, Queen Mary and Tuen Mun Hospital in Hong Kong.
Description
Inclusion Criteria:
- Adult (aged ≥ 18 years)
- Suspected AHF or acute dyspnea
- Symptoms include shortness of breath, swelling of legs, orthopnea, paroxysmal nocturnal dyspnoea, exertional dyspnea or weight gain
Exclusion Criteria:
- Trauma patients
- Pregnancy
- Unstable patients requiring invasive airway intervention
- Patients who refuse to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Testing Cohort
Patients from PWH and TMH
|
Beside echocardiography (to assess the LV function, IVC, pericardial effusion or cardiac tamponade). Blood tests including NT-proBNP for risk stratification. 8 point lung ultrasound to look for B-lines.
Other Names:
|
|
Validation Cohort
Patients from QMH
|
Beside echocardiography (to assess the LV function, IVC, pericardial effusion or cardiac tamponade). Blood tests including NT-proBNP for risk stratification. 8 point lung ultrasound to look for B-lines.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adjudicated acute heart failure diagnosis
Time Frame: Immediately after the 6 month follow-up.
|
The primary outcome for model development and validation will be the adjudicated diagnosis of acute heart failure, as determined by independent review according to ESC criteria.
|
Immediately after the 6 month follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency department and discharge diagnosis of the patients
Time Frame: From enrolment to end of review at 6 months.
|
Secondary outcomes include ED and discharge diagnosis of the patients.
A telephone follow-up and chart view at 6 months will be done to ascertain the subsequent diagnosis of AHF.
|
From enrolment to end of review at 6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin KC Hung, Dr., Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 17, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
January 31, 2029
Study Registration Dates
First Submitted
August 4, 2026
First Submitted That Met QC Criteria
August 4, 2026
First Posted (Actual)
August 10, 2026
Study Record Updates
Last Update Posted (Actual)
August 11, 2026
Last Update Submitted That Met QC Criteria
August 9, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHF Clinical Prediction
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.