Myovista vs NT Pro-BNP Heart Failure Referral Tool

Comparing Myovista wavECG to NT Pro-BNP for Heart Failure Referral

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Myovista® WavECG™

Detailed Description

This is a multi-center, non-interventional, single arm, non-inferiority clinical study of the MyoVista wavECG ability to identify primary care patients for referral to secondary care for diagnosis of heart failure (as defined by BSE (British Society of Echocardiography) guidelines for echo), in direct comparison to BNP/NT-proBNP. The study will be conducted at a maximum of 10 investigational secondary care sites within the United Kingdom, and some/all referring primary care centres for each site. Study subjects presenting at primary care with shortness of breath, risk factors for and/or suspicion of heart failure will be referred to secondary care for 2D transthoracic echocardiogram based on borderline and abnormal BNP/NT-proBNP results as part of the current heart failure pathway as defined by the NICE (National Institute for Health and Care Excellence) guidelines, with the MyoVista wavECG used for the conventional 12 lead ECG reporting and comparison purposes only. MyoVista wavECG results will not be used in the diagnosis of a patient, and/or for the basis of a patient referral to echocardiography for the study duration. In commercial use the MyoVista wavECG will be intended for use in a population of patients being considered for such a referral by providing CWT (Continuous Wavelet Transform) and AI (Artificial Intelligence) derived informatics surrounding an overall summary of left ventricular relaxation abnormalities (High Negative, Negative, Borderline, Positive and Highly Positive). The design of this study will allow for an appropriate evaluation of safety and effectiveness for that population.

The study duration will consist of a single visit for all study subjects, after which the subject's participation in the trial will conclude unless longitudinal study inclusion criteria met and agreed at enrollment (Normal BNP/NT-proBNP, MyoVista wavECG result Negative, Borderline, Positive, Highly Positive).

All study subjects will provide written informed consent for the procedures consistent with the study protocol.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Badri Chandrasekaran; Phone Number: +441793646313; Email: badri.chandrasekaran@nhs.net
• Study Contact Backup: Name: Kim Harman; Phone Number: +441793605796; Email: kim.harman@nhs.net

Study Locations

• United Kingdom
  • Swindon, United Kingdom
    • Great Western Hospitals NHS Foundation Trust
  • Swindon, United Kingdom, SN3 6BB
    • Great Western Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject recruitment will include individuals presenting with shortness of breath and with risk factors for and/or suspicion of heart failure, who are to be screened as per the UK National Institute for Care and Clinical Excellence (NIICE) guidelines using a conventional 12 lead resting ECG, BNP/NT-proBNP and referred for echocardiography as part of their standard care.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Inferior Sensitivity (%) and Specificity (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP	Non-Inferior sensitivity/specificity performance of the MyoVista wavECG to identify patients requiring referral to echo for heart failure diagnosis, compared to the BNP/NT-proBNP measurement	6 months for data collection
Non-Inferior PPV (%) and NPV (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP	Non-Inferior PPV/NPV performance of the MyoVista wavECG to identify patients requiring referral to echo for heart failure diagnosis, compared to the BNP/NT-proBNP measurement	6 months for data collection
Economic analysis of the MyoVista wavECG test compared to BNP/NT-proBNP (£GBP)	Economic analysis of the MyoVista wavECG as a patient referral to echo tool for heart failure diagnosis compared to BNP/NT-proBNP testing, based on performance improvements (sensitivity and specificity) from MyoVista wavECG. Comparison of referral cost implications of improved risk stratification to include MyoVista waveECG test cost/primary care staff time/cardiology staff time/cost of performing echo vs BNP/NT-proBNP test cost/primary care staff time/cardiology staff time/cost of performing echo	6 months for data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity (%) and Specificity (%) performance of MyoVista wavECG to identify patients with systolic dysfunction	MyoVista wavECG ability to identify patients with left ventricular relaxation abnormalities associated impaired systolic function as defined by reduced ejection fraction (<50%)	6 months for data collection
PPV (%) and NPV (%) performance of MyoVista wavECG to identify patients with systolic dysfunction	MyoVista wavECG ability to identify patients with left ventricular relaxation abnormalities associated impaired systolic function as defined by reduced ejection fraction (<50%)	6 months for data collection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity (%) and Specificity (%) performance of the MyoVista wavECG predictive ability	Patients who returned a normal BNP/NT-proBNP test will be tracked for future visits to primary/secondary care related to cardiovascular disease for a period of 24 mths, allowing an evaluation of the MyoVista wavECG's ability to predict and identify patients likely to experience future disease onset	24 months from subject enrolment
PPV (%) and NPV (%) performance of the MyoVista wavECG predictive ability	Patients who returned a normal BNP/NT-proBNP test will be tracked for future visits to primary/secondary care related to cardiovascular disease for a period of 24 mths, allowing an evaluation of the MyoVista wavECG's ability to predict and identify patients likely to experience future disease onset	24 months from subject enrolment

Collaborators and Investigators

• Sponsor: Great Western Hospitals NHS Foundation Trust
• Collaborators: Northern Care Alliance NHS Foundation Trust; North Tees and Hartlepool NHS Foundation Trust; Riverside Medical Center; Royal Cornwall Hospitals Trust; HeartSciences Inc, USA

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): May 31, 2022
• Study Completion (ANTICIPATED): May 31, 2024

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (ACTUAL): October 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Heart Failure; Primary Care; Diagnosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: GWH0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No