Comprehensive Clinical Prediction Rule for Acute Heart Failure
ConditionAcute Heart Failure (AHF)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Trauma patients
Pregnancy
Unstable patients requiring invasive airway intervention
Patients who refuse to participate
Trial population
Adult patients attending the emergency departments of Prince of Wales, Queen Mary and Tuen Mun Hospital in Hong Kong.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Acute Heart Failure Diagnostic Method
Diagnostic testBeside 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.
Treatment groups
560 Participants
are divided into 2 treatment groupsGroup A: Testing Cohort1 intervention
Group B: Validation Cohort1 intervention
Trial outcomes
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.
Time frame
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.
Time frame
From enrolment to end of review at 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese University of Hong Kong
Lead sponsor
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
Source ClinicalTrials.gov
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