An interventional study of NT-proBNP testing in Heart Failure, sponsored by University of Stirling. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Stirling · Not applicable, Interventional, and Diagnostic
Heart failure is a serious condition that can be difficult to diagnose quickly when patients present to hospital with symptoms such as breathlessness. Delays in diagnosis may delay treatment and adversely affect patient outcomes. N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a blood biomarker recommended in national and international guidelines to support the diagnosis of heart failure. Conventional laboratory testing can take several hours before results are available.
This study will evaluate the use of point-of-care NT-proBNP testing, which provides results at the bedside within approximately 12 minutes, in patients presenting to hospital with suspected new heart failure. The study will compare time to heart failure diagnosis, time to treatment initiation, length of hospital stay, 30-day hospital readmission, and 30-day mortality between patients receiving point-of-care NT-proBNP testing and a retrospective comparison cohort managed before its introduction.
In addition, healthcare professionals involved in delivering the service will complete a questionnaire to evaluate the acceptability and feasibility of implementing point-of-care NT-proBNP testing within routine clinical practice. The findings will help determine the clinical and operational impact of point-of-care NT-proBNP testing and inform future service development and research in heart failure care.
Heart failure (HF) is a serious condition in which the heart is unable to pump blood effectively around the body. It affects millions of people worldwide and is a common cause of hospital admission. Symptoms of HF, such as breathlessness, tiredness and swelling, can be difficult to distinguish from other medical conditions, which may lead to delays in diagnosis and treatment. Earlier diagnosis and treatment are associated with improved patient outcomes and may reduce the need for prolonged hospitalisation.
National and international clinical guidelines recommend measuring levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), a hormone released by the heart when it is under strain, to help diagnose or exclude HF. Currently, NT-proBNP samples are typically sent to a laboratory for analysis. Although accurate, laboratory testing may take several hours before results are available, potentially delaying clinical decision-making.
Point-of-care testing (POCT) is an alternative method that enables NT-proBNP levels to be measured at the patient's bedside. Results are available within approximately 12 minutes, allowing clinicians to use the information much earlier during assessment and treatment planning. While POCT has the potential to improve the speed of care, there is limited evidence regarding its impact on clinical outcomes in patients presenting to hospital with suspected new HF.
This study will evaluate whether introducing POCT NT-proBNP testing improves the timeliness of HF diagnosis and treatment compared with usual care. The study will also explore the impact of POCT NT-proBNP testing on hospital outcomes and evaluate healthcare professionals' experiences of implementing the test in routine clinical practice.
The study will be conducted in three phases.
Phase 1: Intervention Cohort
During Phase 1, adults presenting to hospital with symptoms suggestive of new HF will receive POCT NT-proBNP testing as part of their clinical assessment. The test will be performed using a point-of-care device, providing results within minutes of blood collection.
Clinical data will be collected prospectively over a six-month period. The primary outcomes will be:
Time from hospital presentation to confirmed HF diagnosis. Time from hospital presentation to initiation of HF treatment.
Secondary outcomes will include:
Length of hospital stay. Thirty-day hospital readmission. Thirty-day all-cause mortality.
The study will assess whether rapid availability of NT-proBNP results is associated with earlier diagnosis and treatment of HF.
Phase 2: Retrospective Comparison Cohort
Phase 2 will involve reviewing data from patients diagnosed with HF during the six months before the introduction of POCT NT-proBNP testing at the study site. These patients received standard care without access to bedside NT-proBNP testing.
Clinical records will be reviewed to collect the same outcomes measured in Phase 1. Comparing these two cohorts will allow evaluation of whether introduction of POCT NT-proBNP testing changes the speed of diagnosis and treatment and influences subsequent patient outcomes.
Particular attention will be paid to the time taken to reach a diagnosis of HF and the time taken to commence appropriate HF therapy following hospital presentation.
Phase 3: Implementation Evaluation
Successful introduction of new technologies into healthcare depends not only on patient outcomes but also on how acceptable and practical they are for healthcare staff. In Phase 3, multidisciplinary healthcare professionals involved in the use of POCT NT-proBNP testing will be invited to complete a questionnaire evaluating their experiences.
The questionnaire will explore areas such as:
Ease of use of the testing system. Impact on clinical decision-making. Perceived benefits and challenges. Acceptability within routine practice. Feasibility of wider implementation.
Responses will help identify factors that support or hinder successful adoption of POCT NT-proBNP testing within acute care settings.
Data Analysis
Data from the intervention and comparison cohorts will be analysed to compare the time taken to reach important clinical milestones, including HF diagnosis and treatment initiation. Time-to-event (survival) analysis methods will be used to evaluate differences between groups. Additional analyses will examine length of hospital stay, hospital readmission and mortality outcomes.
Questionnaire responses from healthcare professionals will be summarised using descriptive statistical methods to provide an overview of staff experiences and perceptions of implementation.
Expected Impact
The findings of this study will provide evidence regarding the effectiveness of POCT NT-proBNP testing in the assessment of patients with suspected HF. The results will help determine whether faster diagnostic testing can lead to earlier treatment and improved patient outcomes. The implementation evaluation will also provide important information about the practical considerations of introducing POCT NT-proBNP testing into routine clinical care.
The study aims to inform future service development, support evidence-based healthcare decision-making, and determine whether larger-scale evaluation of POCT NT-proBNP testing is warranted.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 252 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Stirling is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are assessed within unscheduled care who are suspected to have signs and symptoms of heart failure, will be tested at the point of care with LumiraDx device (CE Mark certification June 2022). Data will be collected on the outcome of the test, together with key demographic and clinical history data. In this study POC NT-proBNP level is the independent variable (the control variable) and the primary dependent variables (outcome variables) are time to new HF diagnosis and treatment initiation.
Diagnostic Test: NT-proBNP testing
point of care blood testing
Time to New Heart Failure Diagnosis
Time (hours) from hospital presentation to confirmed heart failure diagnosis.
Time frame: From hospital presentation until confirmed heart failure diagnosis by echocardiography, assessed up to hospital discharge (maximum 90 days).
Time to Heart Failure Treatment Initiation.
Time (hours) from hospital presentation to initiation of heart failure therapy.
Time frame: From hospital presentation until initiation of heart failure treatment, assessed up to hospital discharge (maximum 90 days).
Length of Hospital Stay
Length of stay from hospital admission to hospital discharge, measured in days.
Time frame: Through hospital discharge, up to 90 days.
30-Day Hospital Readmission.
The proportion of participants requiring unplanned hospital readmission following discharge from the index hospital admission.
Time frame: Within 30 days following hospital discharge.
30-Day Mortality
All-cause mortality occurring following presentation with suspected heart failure.
Time frame: Within 30 days following hospital presentation.
Plan to share: No — All data is anonymised.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Stirling