Comparing Myovista wavECG to NT Pro-BNP for Heart Failure Referral
Trial ID: NCT05068154
Status: UNKNOWN
Study type: OBSERVATIONAL
Start date: 2021-11-01
Completion date: 2024-05-31
Sponsor: Great Western Hospitals NHS Foundation Trust
Collaborators: Royal Cornwall Hospitals Trust; Northern Care Alliance NHS Foundation Trust; North Tees and Hartlepool NHS Foundation Trust; Riverside Medical Center; HeartSciences Inc, USA
Conditions: Heart Failure
Interventions: Myovista® WavECG™
Locations: Great Western Hospitals NHS Foundation Trust; Great Western Hospitals NHS Foundation Trust
Countries: United Kingdom; United Kingdom
Enrollment: 1200
Age range: 18 Years - 110 Years
Sex: ALL

Summary:
It is hypothesised that the MyoVista wavECG has the potential to show non inferior sensitivity and specificity compared to the current heart failure pathway screening tools of BNP/NT-proBNP and 12 lead resting ECG, but has the advantage of providing a single, familiar, inexpensive point of care test which provides point of care results and can act as a prescreen, or in circumstances replacement to BNP/NTpro-BNP testing, and eliminate a proportion of the unnecessary testing and echo referrals.

A comparative performance analysis of the modalities will form the basis for the study with subsequent reporting on the financial impact and societal benefits of any potential pathway change.

Eligibility criteria:
Inclusion Criteria:

1. Subjects presenting with shortness of breath and risk factors for and/or suspicion of having early-stage heart failure during initial clinical assessment.
2. Informed Consent - The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).
3. Sinus rhythm - Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below)
4. Age - Subject is ≥18 years of age

Exclusion Criteria:

1. Acute Disease - The subject has current acute coronary syndrome, decompensated heart failure, stroke, or previous history of MI.
2. Prior Cardiac Procedures - The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.
3. Rhythm Abnormalities - Conventional ECG results indicating a lack of sinus rhythm and/or automatic heart failure pathway RULE IN rhythms including active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block
4. Pregnancy - The subject self declares pregnancy at the time of the study testing
5. Chest deformities - The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
6. Measurement Interference - Subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ECG and/or echocardiogram measurements.
7. Study Participation - The subject is enrolled in another clinical study that may interfere with MyoVista or echocardiogram measurements. Exceptions to this may be approved prior to enrollment.

Outcomes:
Non-Inferior Sensitivity (%) and Specificity (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP; Non-Inferior PPV (%) and NPV (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP; Economic analysis of the MyoVista wavECG test compared to BNP/NT-proBNP (£GBP)