Heart failure Circulatory System
Conditions
Interventions
We will invite adults who have been referred by their primary care to a specialist heart assessment because of symptoms and a raised NTproBNP blood test suggesting possible heart stress. These patient
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged >=18 years 2. Patient with suspected for heart failure and referred to specialised heart failure investigation/centre 3. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who are unwilling or unable to provide informed consent 2. Patients known to have heart failure or any previous measurement of LVEF <50%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from initial handheld heart scan assessment to confirmed diagnosis of heart failure measured using review of electronic healthcare records and study case report forms to determine the date of handheld heart scan assessment and the date of confirmed heart failure diagnosis at baseline assessment until confirmed diagnosis of heart failure (up to 6-months after enrolment);Time from initial handheld heart scan assessment to initiation of guideline-directed heart failure treatment measured using review of electronic healthcare records, prescribing records and study case report forms to determine the date of handheld heart scan assessment and the date of first heart failure treatment initiation at baseline assessment until initiation of heart failure treatment (up to 6-months after enrolment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Agreement between AI-derived handheld heart scan measurements and specialist transthoracic echocardiography measurements, including left ventricular ejection fraction and other predefined cardiac parameters measured using comparison of handheld heart scan device outputs with specialist transthoracic echocardiography measurements assessed by Bland–Altman analysis, correlation coefficients and diagnostic agreement measures at baseline assessment 2. Proportion of handheld heart scans that are of sufficient quality for clinical interpretation and AI analysis measured using predefined image quality criteria to determine the proportion of analysable scans at baseline assessment 3. Patient satisfaction with the community-based handheld heart scan pathway measured using the Patient Satisfaction Questionnaire (PSQ18) following completion of the diagnostic pathway 4. Practitioner competency and confidence in performing and interpreting handheld heart scan assessments measured using the Practitioner Competency and Confidence questionnaire (Bull and Dale 2021, STAI-6) at baseline training assessment and study completion 5. Proportion of handheld heart scans identifying clinically actionable cardiac findings requiring further investigation or treatment measured using review of handheld heart scan reports, specialist transthoracic echocardiography reports and clinical records at baseline assessment and completion of the diagnostic pathway 6. Incidence of adverse events related to the handheld heart scan pathway measured using review of participant medical records, adverse event reporting forms and study documentation throughout study participation 7. Resource utilisation and care pathway metrics, including number of appointments, referrals and investigations measured using review of healthcare records, service activity data and study case report forms throughout the diagnostic pathway until completion of follow-up 8. Healthcare resource use and costs associated with the | — |
Countries
England, United Kingdom
Contacts
Public ContactNurul Abdul Samad
Outcome results
None listed