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Comprehensive Clinical Prediction Rule for Acute Heart Failure

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07754084
Enrollment
560
Registered
2026-08-10
Start date
2026-08-17
Completion date
2029-01-31
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure (AHF)

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTAcute Heart Failure Diagnostic Method

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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER
Prince of Wales Hospital, Shatin, Hong Kong
CollaboratorOTHER
The University of Hong Kong
CollaboratorOTHER
Tuen Mun Hospital, Hospital Authority, Hong Koong
CollaboratorUNKNOWN
Queen Mary Hospital, Hong Kong
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adjudicated acute heart failure diagnosisImmediately 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

MeasureTime frameDescription
Emergency department and discharge diagnosis of the patientsFrom 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.

Countries

Hong Kong

Contacts

CONTACTTheresa Hui
theresahui@cuhk.edu.hk+85235051698
PRINCIPAL_INVESTIGATORKevin KC Hung, Dr.

Chinese University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026