Comprehensive Clinical Prediction Rule for Acute Heart Failure

NCT07754084 | Not Yet Recruiting DMC

• 1 other identifier: AHF Clinical Prediction
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 3

Brief 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 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)

Keywords

Acute Heart Failure; LUS; CXR; ECG; NT-proBNP

Outcome Measures

Primary Outcomes (1)

• 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.

  Will be done right after the 6 month follow-up.

Secondary Outcomes (1)

• Emergency department and discharge diagnosis of the patients

  From enrolment to end of review at 6 months.

Study Arms (2)

Testing Cohort

Patients from PWH and TMH

Diagnostic Test: Acute Heart Failure Diagnostic Method

Validation Cohort

Patients from QMH

Diagnostic Test: Acute Heart Failure Diagnostic Method

Interventions

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.

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

Testing Cohort; Validation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Trauma patients
• Pregnancy
• Unstable patients requiring invasive airway intervention
• Patients who refuse to participate

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• The University of Hong Kong: collaborator
• Tuen Mun Hospital, Hospital Authority, Hong Koong: collaborator
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (3)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Diagnostic Imaging; Electrocardiography; Echocardiography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis; Cardiac Imaging Techniques; Ultrasonography

Study Officials

• Kevin KC Hung, Dr.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Hui

CONTACT

+85235051698; theresahui@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Accident and Emergency Medicine Academic Unit

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

HK (3)