Acute Heart Failure (AHF)NCT07754084
Comprehensive Clinical Prediction Rule for Acute Heart Failure
An observational study of Acute Heart Failure (AHF), run by Chinese University of Hong Kong at 3 sites in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Heart Failure (AHF)
- What is being tested?
- Acute Heart Failure Diagnostic Method
- How many people
- 560 participants
- Where
- 3 sitesHong Kong
- Study dates
- 17 Aug 2026to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients attending the emergency departments of Prince of Wales, Queen Mary and Tuen Mun Hospital in Hong Kong.
Who may be able to join
- 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
Who cannot join
- Trauma patients
- Pregnancy
- Unstable patients requiring invasive airway intervention
- Patients who refuse to participate
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong3 sites
Prince of Wales Hospital
Hong Kong
Theresa Hui, +85235051698, theresahui@cuhk.edu.hk
Kevin KC Hung, Dr.
Queen Mary Hospital
Hong Kong
Rex PK Lam, Dr., +85239179175, lampkrex@hku.hk
Rex PK Lam, Dr.
Tuen Mun Hospital
Hong Kong
Jeffrey HT Fung, Dr., +85224685111, funght@ha.org.hk
Jeffrey HT Fung, Dr.
About this study
Official title: 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.
- Conditions
- Acute Heart Failure (AHF)
- Being tested
- Acute Heart Failure Diagnostic Method
- Keywords
- Acute Heart Failure, LUS, CXR, ECG, NT-proBNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Heart Failure Diagnostic MethodDiagnostic test
Also called Chest X-ray, Lung ultrasound, NT-proBNP, Brest score
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.
| Study group | Role | What they receive |
|---|---|---|
| Testing Cohort | Patients from PWH and TMH Receives: Diagnostic Test: Acute Heart Failure Diagnostic Method | |
| Validation Cohort | Patients from QMH Receives: Diagnostic Test: Acute Heart Failure Diagnostic Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjudicated acute heart failure diagnosis
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.
Measured: Immediately after the 6 month follow-up.
Secondary outcomes (1)
Emergency department and discharge diagnosis of the patients
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.
Measured: From enrolment to end of review at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, The University of Hong Kong, Tuen Mun Hospital, Hospital Authority, Hong Koong, Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, Kevin HUNG Kei-ching, Chinese University of Hong Kong
- Investigators
- Kevin KC Hung, Dr., Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754084
- Sponsor's protocol ID
- AHF Clinical Prediction
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Comprehensive Clinical Prediction Rule for the Diagnosis of Acute Heart Failure in the Emergency Department
- ClinicalTrials.gov ID
- NCT07754084
- Acronym / sponsor ID
- AHF Clinical Prediction
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- Acute Heart Failure, LUS, CXR, ECG, NT-proBNP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, The University of Hong Kong, Tuen Mun Hospital, Hospital Authority, Hong Koong, Queen Mary Hospital, Hong Kong
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing Cohort | – | Diagnostic Test: Acute Heart Failure Diagnostic MethodPatients from PWH and TMH |
| Validation Cohort | – | Diagnostic Test: Acute Heart Failure Diagnostic MethodPatients from QMH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients attending the emergency departments of Prince of Wales, Queen Mary and Tuen Mun Hospital in Hong Kong.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Trauma patients
- Pregnancy
- Unstable patients requiring invasive airway intervention
- Patients who refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Heart Failure Diagnostic MethodAlso: Chest X-ray, Lung ultrasound, NT-proBNP, Brest scoreBeside 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. | Diagnostic test | Testing Cohort, Validation Cohort |
Primary outcome
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.
1 secondary outcome
Emergency department and discharge diagnosis of the patients
Time frame: From enrolment to end of review at 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin KC Hung, Dr. principal investigator
Chinese University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure (AHF), run by Chinese University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresa Hui (+85235051698, theresahui@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjudicated acute heart failure diagnosis (time frame: Immediately after the 6 month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.