Heart FailureNCT05068154
Myovista vs NT Pro-BNP Heart Failure Referral Tool
An observational study of Heart Failure, run by Great Western Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Myovista® WavECG™
- How many people
- 1,200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Nov 2021to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
- Sinus rhythm - Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below)
- Age - Subject is ≥18 years of age
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Great Western Hospitals NHS Foundation Trust
Swindon, SN3 6BB
Great Western Hospitals NHS Foundation Trust
Swindon
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Myovista® WavECG™
- Keywords
- Diagnosis, Heart Failure, Primary Care
- Medical subject headings
- Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months for data collection
Secondary outcomes (2)
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%)
Measured: 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%)
Measured: 6 months for data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Western Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Cornwall Hospitals Trust, Northern Care Alliance NHS Foundation Trust, North Tees and Hartlepool NHS Foundation Trust, Riverside Medical Center, HeartSciences Inc, USA
- Responsible party
- Principal investigator, Dr Badri Chandrasekaran, Great Western Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068154
- Sponsor's protocol ID
- GWH0002
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Myovista wavECG to NT Pro-BNP for Heart Failure Referral
- ClinicalTrials.gov ID
- NCT05068154
- Acronym / sponsor ID
- GWH0002
- Conditions
- Heart Failure
- Keywords
- Diagnosis, Heart Failure, Primary Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Great Western Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal Cornwall Hospitals Trust, Northern Care Alliance NHS Foundation Trust, North Tees and Hartlepool NHS Foundation Trust, Riverside Medical Center, HeartSciences Inc, USA
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
- Sinus rhythm - Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below)
- Age - Subject is ≥18 years of age
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myovista® WavECG™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 | Diagnostic test | – |
Primary outcome
Non-Inferior Sensitivity (%) and Specificity (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP
Time frame: 6 months for data collection
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
Non-Inferior PPV (%) and NPV (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP
Time frame: 6 months for data collection
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
Economic analysis of the MyoVista wavECG test compared to BNP/NT-proBNP (£GBP)
Time frame: 6 months for data collection
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
2 secondary outcomes
Sensitivity (%) and Specificity (%) performance of MyoVista wavECG to identify patients with systolic dysfunction
Time frame: 6 months for data collection
PPV (%) and NPV (%) performance of MyoVista wavECG to identify patients with systolic dysfunction
Time frame: 6 months for data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Great Western Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Badri Chandrasekaran (+441793646313, badri.chandrasekaran@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Inferior Sensitivity (%) and Specificity (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP (time frame: 6 months for data collection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.