Myovista vs NT Pro-BNP Heart Failure Referral Tool

NCT05068154 | Unknown DMC

• 1 other identifier: GWH0002
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure

Keywords

Diagnosis; Heart Failure; Primary Care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Sensitivity (%) and Specificity (%) performance of MyoVista wavECG to identify patients with systolic dysfunction

  6 months for data collection

• PPV (%) and NPV (%) performance of MyoVista wavECG to identify patients with systolic dysfunction

  6 months for data collection

Other Outcomes (2)

• Sensitivity (%) and Specificity (%) performance of the MyoVista wavECG predictive ability

  24 months from subject enrolment

• PPV (%) and NPV (%) performance of the MyoVista wavECG predictive ability

  24 months from subject enrolment

Interventions

Myovista® WavECG™ DIAGNOSTIC_TEST

The MyoVista wavECG Device uses wavelet signal processing to extract frequency information from the acquired 12-lead ECG signal which is then analysed using artificial intelligence to provide information relating to left ventricular relaxation abnormalities

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects presenting with shortness of breath and risk factors for and/or suspicion of having early-stage heart failure during initial clinical assessment.
• 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).
• Age - Subject is ≥18 years of age

You may not qualify if:

• Acute Disease - The subject has current acute coronary syndrome, decompensated heart failure, stroke, or previous history of MI.
• 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.
• 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
• Pregnancy - The subject self declares pregnancy at the time of the study testing
• Chest deformities - The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
• Measurement Interference - Subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ECG and/or echocardiogram measurements.
• 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.

Sponsors & Collaborators

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

Study Sites (2)

Great Western Hospitals NHS Foundation Trust

Swindon, SN3 6BB, United Kingdom

Location

Great Western Hospitals NHS Foundation Trust

Swindon, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Badri Chandrasekaran

CONTACT

+441793646313; badri.chandrasekaran@nhs.net

Kim Harman

CONTACT

+441793605796; kim.harman@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist, Director of R&I

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 5, 2021
• Study Start: November 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2024
• Last Updated: October 5, 2021

Record last verified: 2021-09

Locations

GB (2)