Comprehensive Clinical Prediction Rule for Acute Heart Failure

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.

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Key information

Conditions

Acute Heart Failure (AHF)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital, Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute Heart Failure Diagnostic Method

Diagnostic Test

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: Chest X-ray, Lung ultrasound, NT-proBNP, Brest score, Electrocardiogram, Echocardiogram

Primary outcomes

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.

Secondary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Theresa Hui

CONTACT

[email protected]

+85235051698

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
The University of Hong Kong
Tuen Mun Hospital, Hospital Authority, Hong Koong

Registry information

Official study title

Establishing a Comprehensive Clinical Prediction Rule for the Diagnosis of Acute Heart Failure in the Emergency Department

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Aug 10, 2026
Registry last updated: Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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