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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
        • Contact:
        • Principal Investigator:
          • Rex PK Lam, Dr.
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
        • Contact:
        • Principal Investigator:
          • Kevin KC Hung, Dr.
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Testing Cohort
Patients from PWH and TMH
Diagnostic test: Acute 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.

Other Names:
  • Echocardiogram
  • Chest X-ray
  • Electrocardiogram
  • Lung ultrasound
  • NT-proBNP
  • Brest score
Validation Cohort
Patients from QMH
Diagnostic test: Acute 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.

Other Names:
  • Echocardiogram
  • Chest X-ray
  • Electrocardiogram
  • Lung ultrasound
  • NT-proBNP
  • Brest score

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital, Hospital Authority, Hong Koong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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