Point of Care NT-proBNP Testing for Suspected New Heart Failure Acute Care

NCT07793968 | Active Not Recruiting

• 1 other identifier: 3705
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure

Keywords

NT-proBNP testing; Unscheduled care; Point of care testing; Heart Failure; New Heart Failure

Outcome Measures

Primary Outcomes (2)

• Time to New Heart Failure Diagnosis

  Time (hours) from hospital presentation to confirmed heart failure diagnosis.

  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.

  From hospital presentation until initiation of heart failure treatment, assessed up to hospital discharge (maximum 90 days).

Secondary Outcomes (3)

• Length of Hospital Stay

  Through hospital discharge, up to 90 days.

• 30-Day Hospital Readmission.

  Within 30 days following hospital discharge.

• 30-Day Mortality

  Within 30 days following hospital presentation.

Study Arms (1)

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.

Diagnostic Test: NT-proBNP testing

Interventions

NT-proBNP testing DIAGNOSTIC_TEST

point of care blood testing

Phase 1: POCT NT-proBNP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous or existing clinical diagnosis of heart failure
• Aged less than 18 years
• Lacks capacity to provide informed consent
• Acute myocardial infarction at presentation

Sponsors & Collaborators

• University of Stirling: lead

Study Sites (1)

University Hospital Crosshouse

Kilmarnock, East Ayrshire, KA2 0BE, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jayne Donaldson

  University of Stirling

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: August 31, 2026
• Study Start: April 30, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)