Heart FailureNCT07793968
Point of Care NT-proBNP Testing for Suspected New Heart Failure Acute Care
A study testing NT-proBNP testing in people with Heart Failure, run by University of Stirling at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- NT-proBNP testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Presenting with new suspected heart failure
- Presenting with unexplained breathlessness suggestive of heart failure
- Able to provide written informed consent
- Has capacity to consent to study participation
Who cannot join
- Previous or existing clinical diagnosis of heart failure
- Aged less than 18 years
- Lacks capacity to provide informed consent
- Acute myocardial infarction at presentation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Crosshouse
Kilmarnock, East Ayrshire, KA2 0BE
About this study
Official title: Evaluating the Effectiveness and Implementation of Point-of-Care NT-proBNP Testing in Acute Care for Patients With Newly Suspected Heart Failure: A Hybrid Effectiveness-Implementation Study
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- NT-proBNP testing
- Keywords
- NT-proBNP testing, Unscheduled care, Point of care testing, Heart Failure, New Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-proBNP testingDiagnostic test
point of care blood testing
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: POCT NT-proBNP | Other | 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. Receives: Diagnostic Test: NT-proBNP testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to New Heart Failure Diagnosis
Time (hours) from hospital presentation to confirmed heart failure diagnosis.
Measured: 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.
Measured: From hospital presentation until initiation of heart failure treatment, assessed up to hospital discharge (maximum 90 days).
Secondary outcomes (3)
Length of Hospital Stay
Length of stay from hospital admission to hospital discharge, measured in days.
Measured: 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.
Measured: Within 30 days following hospital discharge.
30-Day Mortality
All-cause mortality occurring following presentation with suspected heart failure.
Measured: Within 30 days following hospital presentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Apr 2024
- Primary completion31 Mar 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a non-randomised interventional study evaluating the impact of point-of-care N-terminal pro-B-type natriuretic peptide (POCT NT-proBNP) testing on the diagnosis and management of adults presenting with suspected new heart failure. Participants in the intervention cohort will receive POCT NT-proBNP testing as part of routine clinical assessment. Clinical outcomes will be compared with a retrospective cohort of patients managed before implementation of POCT NT-proBNP testing who received standard care. Primary outcomes are time from hospital presentation to heart failure diagnosis and time to treatment initiation. Secondary outcomes include length of hospital stay, 30-day hospital readmission and 30-day mortality. Healthcare professionals involved in the intervention will complete a validated questionnaire to evaluate implementation outcomes, including acceptability, feasibility and impact on clinical practice.
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayne Donaldson, Study chair, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793968
- Sponsor's protocol ID
- 3705
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data is anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness and Implementation of Point-of-Care NT-proBNP Testing in Acute Care for Patients With Newly Suspected Heart Failure: A Hybrid Effectiveness-Implementation Study
- ClinicalTrials.gov ID
- NCT07793968
- Acronym / sponsor ID
- 3705
- Conditions
- Heart Failure
- Keywords
- NT-proBNP testing, Unscheduled care, Point of care testing, Heart Failure, New Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-randomised interventional study evaluating the impact of point-of-care N-terminal pro-B-type natriuretic peptide (POCT NT-proBNP) testing on the diagnosis and management of adults presenting with suspected new heart failure. Participants in the intervention cohort will receive POCT NT-proBNP testing as part of routine clinical assessment. Clinical outcomes will be compared with a retrospective cohort of patients managed before implementation of POCT NT-proBNP testing who received standard care. Primary outcomes are time from hospital presentation to heart failure diagnosis and time to treatment initiation. Secondary outcomes include length of hospital stay, 30-day hospital readmission and 30-day mortality. Healthcare professionals involved in the intervention will complete a validated questionnaire to evaluate implementation outcomes, including acceptability, feasibility and impact on clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: POCT NT-proBNP | Other | Diagnostic Test: NT-proBNP testingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Presenting with new suspected heart failure
- Presenting with unexplained breathlessness suggestive of heart failure
- Able to provide written informed consent
- Has capacity to consent to study participation
Key exclusion criteria (4 listed)
- Previous or existing clinical diagnosis of heart failure
- Aged less than 18 years
- Lacks capacity to provide informed consent
- Acute myocardial infarction at presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-proBNP testingpoint of care blood testing | Diagnostic test | Phase 1: POCT NT-proBNP |
Primary outcome
Time to New Heart Failure Diagnosis
Time frame: From hospital presentation until confirmed heart failure diagnosis by echocardiography, assessed up to hospital discharge (maximum 90 days).
Time (hours) from hospital presentation to confirmed heart failure diagnosis.
Time to Heart Failure Treatment Initiation.
Time frame: From hospital presentation until initiation of heart failure treatment, assessed up to hospital discharge (maximum 90 days).
Time (hours) from hospital presentation to initiation of heart failure therapy.
3 secondary outcomes
Length of Hospital Stay
Time frame: Through hospital discharge, up to 90 days.
30-Day Hospital Readmission.
Time frame: Within 30 days following hospital discharge.
30-Day Mortality
Time frame: Within 30 days following hospital presentation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. All data is anonymised.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayne Donaldson study chair
University of Stirling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NT-proBNP testing in people with Heart Failure, run by University of Stirling at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to New Heart Failure Diagnosis (time frame: From hospital presentation until confirmed heart failure diagnosis by echocardiography, assessed up to hospital discharge (maximum 90 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.