Heart FailureHF-CGMNCT02803879
Assessing the Capability of Cardiogoniometry (CGM) to Detect Changes in Cardiac Resynchronisation Therapy Device Settings
A study testing Cardiogoniometry in people with Heart Failure, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Some patients with heart failure require treatment called cardiac-resynchronisation therapy (CRT) which involves putting a pacemaker into the heart to make both ventricles (the lower chambers of the heart) contract together, making the pumping of the blood to the rest of the body more efficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiogoniometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Aug 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attending follow up clinic with a CRT device implanted.
- Patients have to be receiving CRT therapy - in other words, the device has to be functioning correctly.
- Aged 18 or over.
- The patient has been informed of the nature of the study and has provided full written informed consent.
Who cannot join
- Patients unable to give informed consent including those with communication difficulties due to poor English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital
Hull, East Yorkshire, HU16 5JQ
About this study
Some patients with heart failure require treatment called cardiac-resynchronisation therapy (CRT) which involves putting a pacemaker into the heart to make both ventricles (the lower chambers of the heart) contract together, making the pumping of the blood to the rest of the body more efficient.
it is important to get the CRT pacemaker checked to make sure that it is working correctly and performing its job. However, it can be difficult to adjust the settings of the pacemaker just the right amount to ensure the heart is pumping efficiently.
Read more
One of the ways this can be done is by using a special machine which uses ultrasound to make a 2-dimensional image of the heart called an echocardiogram. This technique can also be used to measure the flow of blood in the heart and calculate how efficient it is at pumping blood. However adjusting the settings of the pacemaker with this device is difficult to use and time consuming.
Electrocardiogram (ECG) a 2-dimensional electrical tracing of the hearts activity is another tool used to help adjust the settings of pacemakers, to make the heart pump more efficiently. Furthermore, recent research has shown that this is better than echocardiogram at optimising pacemaker device settings.
A new type of ECG called cardiogoniometry (CGM) has recently been developed which creates a 3-dimensional view of the hearts electrical activity and has already been shown to be better than normal ECG at diagnosing certain conditions like angina and heart attacks. However it has never been used to try optimise the settings of the pacemakers used in CRT and may be quicker and easier to use than then other methods available. More importantly it is hoped by doing this it will reduce the symptoms that patients suffer as it is making the heart pump more efficiently.
As it has been untested and never used in this setting before, and there it is necessary to find out if the CGM machine will recognise when the settings on the pacemaker are changed.
The aims of this study is to see if the CGM machine can pick up changes to pacemaker settings, with the hope of running a later study to see if it can be used to optimise settings on the pacemaker used in CRT.
Read the detailed description
Cardiac resynchronisation therapy (CRT) improves symptoms and quality of life and improves the prognosis of patients with chronic heart failure. CRT works by improving co-ordination of cardiac contraction, and is indicated in people with heart failure and left bundle branch block (LBBB) on an ECG. The importance of LBBB is that it indicates that the electricity is spreading only very slowly over the surface of the heart with each heart beat, thereby making contraction very "dyssynchronous"; that is, instead of all the heart muscle contracting simultaneously, parts contract and are relaxing before other parts even start to contract.
With a standard pacemaker, a pacing lead is implanted in the right ventricle. In those patients with a normal heart rhythm ("sinus rhythm"), a second lead is usually placed in the right atrium close to the heart's natural pacemaker. The lead in the ventricle can then track the heart's natural heart rate as detected by the lead in the atrium, or, if the natural rate is too slow, the pacemaker can sequentially pace the atrium and then the ventricle.
A CRT system is similar, but with the addition of an extra lead positioned to pace the left ventricle. Now, the pacemaker is able to stimulate both left and right ventricles simultaneously, restoring the normal co-ordination of ventricular contraction.
Approximately 25% of patients do not achieve significant clinical benefit with CRT. Such patients are termed "non-responders", and lack of response is typically measured as a failure to improve exercise capacity with CRT, or a failure of the heart to improve on echocardiography. One option to reduce the number of non-responders may be to optimise the CRT device by adjusting its settings based on clinical variables (such as ECG and echocardiogram findings). Both ECG and echocardiogram optimisation give similar results in terms of clinical response to CRT, but patients who had their CRT optimised using ECG variables had a significantly greater impact on echocardiographic response, that is a greater proportion of that group had a LV end-systolic volume reduction >10%) 3. Another possibility for optimising CRT is cardiogoniometry (CGM), which is what the study aims to investigate. CGM is form of 3D vector electrocardiography which can provide quantitative analysis of myocardial depolarisation and repolarisation. Like standard 12 lead electrocardiogram (ECG), CGM uses different electrodes to identify electrical potential gradients produced by cardiac electrical activity. The ECG can only visually represent this information in a two dimensional way, whereas CGM can create a three dimensional display. Electrode placement is important: and complex mathematical modelling is used to generate the displays. CGM gives the same output as a standard ECG. One additional output is vector loop graphs. These are sequentially plotted values of electrical activity of the heart in the x, y and z axis, in three orthogonal planes. When the vector loops follow the same pathway it means that the electrical activity of the heart is following the same pathway with each ventricular depolarisation and repolarisation. By contrast, when there is abnormal electrical conduction, the vector loop pathways can vary. CGM is useful for identifying stable coronary artery disease and recognising the acute coronary syndromes, but its clinical value outside patients with acute ischaemic heart disease is unclear. This feasibility study aims to see if CGM can detect the different settings of a CRT device, by assessing the CGM vector loops with different device settings.
- Conditions
- Heart Failure
- Being tested
- Cardiogoniometry
- Keywords
- cardiac resynchronisation therapy, cardiogoniometry
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiogoniometryDevice
| Study group | Role | What they receive |
|---|---|---|
| Cardiogoniometry (CGM) | Experimental | All patients attending clinic for follow up appointments following the implantation of a CRT device will be eligible for inclusion in the study. If they consent for enrolment in the study each patient will undergo a series of 4 CGM recordings whilst in their follow up appointment. They will undergo each of these during different pacemaker settings. These are: 1) No pacing, 2) Paced from the right ventricular lead; 3) Paced from the left ventricular lead and 4) Paced from both ventricular leads. After this has been done the participants involvement in the study will have finished. Receives: Device: Cardiogoniometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cardiac axis with no pacing
Mean cardiac axis of participants when they are not being paced will be calculated with 95% confidence intervals.
Measured: Within the first 30 days after end of participant enrollment
Mean cardiac axis with rv pacing
Mean cardiac axis of participants when they are being paced from the RV will be calculated with 95% confidence intervals.
Measured: Within the first 30 days after end of participant enrollment
Mean cardiac axis with lv pacing
Mean cardiac axis of participants when they are being paced from the LV will be calculated with 95% confidence intervals.
Measured: Within the first 30 days after end of participant enrollment
Mean cardiac axis with biv pacing
Mean cardiac axis of participants when they are being biventricular paced will be calculated with 95% confidence intervals.
Measured: Within the first 30 days after end of participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803879
- Sponsor's protocol ID
- 15/NW/0479
- Acronym
- HF-CGM
- Status last verified
- Jul 2019
- First submitted
- 18 Feb 2016
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Brown OI, Nikolaidou T, Beddoes G, Hoye A, Clark AL. The HF-CGM Study: An Analysis of Cardiogoniometric Axes in Patients With Cardiac Resynchronization Therapy. IEEE Trans Biomed Eng. 2018 Aug;65(8):1711-1716. doi: 10.1109/TBME.2017.2769060. Epub 2017 Nov 2.
PubMed 29989935
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Capability of Cardiogoniometry (CGM) to Detect Changes in Cardiac Resynchronisation Therapy Device Settings
- ClinicalTrials.gov ID
- NCT02803879
- Acronym / sponsor ID
- HF-CGM / 15/NW/0479
- Conditions
- Heart Failure
- Keywords
- cardiac resynchronisation therapy, cardiogoniometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
Some patients with heart failure require treatment called cardiac-resynchronisation therapy (CRT) which involves putting a pacemaker into the heart to make both ventricles (the lower chambers of the heart) contract together, making the pumping of the blood to the rest of the body more efficient.
it is important to get the CRT pacemaker checked to make sure that it is working correctly and performing its job. However, it can be difficult to adjust the settings of the pacemaker just the right amount to ensure the heart is pumping efficiently.
One of the ways this can be done is by using a special machine which uses ultrasound to make a 2-dimensional image of the heart called an echocardiogram. This technique can also be used to measure the flow of blood in the heart and calculate how efficient it is at pumping blood. However adjusting the settings of the pacemaker with this device is difficult to use and time consuming.
Electrocardiogram (ECG) a 2-dimensional electrical tracing of the hearts activity is another tool used to help adjust the settings of pacemakers, to make the heart pump more efficiently. Furthermore, recent research has shown that this is better than echocardiogram at optimising pacemaker device settings.
A new type of ECG called cardiogoniometry (CGM) has recently been developed which creates a 3-dimensional view of the hearts electrical activity and has already been shown to be better than normal ECG at diagnosing certain conditions like angina and heart attacks. However it has never been used to try optimise the settings of the pacemakers used in CRT and may be quicker and easier to use than then other methods available. More importantly it is hoped by doing this it will reduce the symptoms that patients suffer as it is making the heart pump more efficiently.
As it has been untested and never used in this setting before, and there it is necessary to find out if the CGM machine will recognise when the settings on the pacemaker are changed.
The aims of this study is to see if the CGM machine can pick up changes to pacemaker settings, with the hope of running a later study to see if it can be used to optimise settings on the pacemaker used in CRT.
Detailed description
Cardiac resynchronisation therapy (CRT) improves symptoms and quality of life and improves the prognosis of patients with chronic heart failure. CRT works by improving co-ordination of cardiac contraction, and is indicated in people with heart failure and left bundle branch block (LBBB) on an ECG. The importance of LBBB is that it indicates that the electricity is spreading only very slowly over the surface of the heart with each heart beat, thereby making contraction very "dyssynchronous"; that is, instead of all the heart muscle contracting simultaneously, parts contract and are relaxing before other parts even start to contract.
With a standard pacemaker, a pacing lead is implanted in the right ventricle. In those patients with a normal heart rhythm ("sinus rhythm"), a second lead is usually placed in the right atrium close to the heart's natural pacemaker. The lead in the ventricle can then track the heart's natural heart rate as detected by the lead in the atrium, or, if the natural rate is too slow, the pacemaker can sequentially pace the atrium and then the ventricle.
A CRT system is similar, but with the addition of an extra lead positioned to pace the left ventricle. Now, the pacemaker is able to stimulate both left and right ventricles simultaneously, restoring the normal co-ordination of ventricular contraction.
Approximately 25% of patients do not achieve significant clinical benefit with CRT. Such patients are termed "non-responders", and lack of response is typically measured as a failure to improve exercise capacity with CRT, or a failure of the heart to improve on echocardiography. One option to reduce the number of non-responders may be to optimise the CRT device by adjusting its settings based on clinical variables (such as ECG and echocardiogram findings). Both ECG and echocardiogram optimisation give similar results in terms of clinical response to CRT, but patients who had their CRT optimised using ECG variables had a significantly greater impact on echocardiographic response, that is a greater proportion of that group had a LV end-systolic volume reduction >10%) 3. Another possibility for optimising CRT is cardiogoniometry (CGM), which is what the study aims to investigate. CGM is form of 3D vector electrocardiography which can provide quantitative analysis of myocardial depolarisation and repolarisation. Like standard 12 lead electrocardiogram (ECG), CGM uses different electrodes to identify electrical potential gradients produced by cardiac electrical activity. The ECG can only visually represent this information in a two dimensional way, whereas CGM can create a three dimensional display. Electrode placement is important: and complex mathematical modelling is used to generate the displays. CGM gives the same output as a standard ECG. One additional output is vector loop graphs. These are sequentially plotted values of electrical activity of the heart in the x, y and z axis, in three orthogonal planes. When the vector loops follow the same pathway it means that the electrical activity of the heart is following the same pathway with each ventricular depolarisation and repolarisation. By contrast, when there is abnormal electrical conduction, the vector loop pathways can vary. CGM is useful for identifying stable coronary artery disease and recognising the acute coronary syndromes, but its clinical value outside patients with acute ischaemic heart disease is unclear. This feasibility study aims to see if CGM can detect the different settings of a CRT device, by assessing the CGM vector loops with different device settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiogoniometry (CGM) | Experimental | Device: CardiogoniometryAll patients attending clinic for follow up appointments following the implantation of a CRT device will be eligible for inclusion in the study. If they consent for enrolment in the study each patient will undergo a series of 4 CGM recordings whilst in their follow up appointment. They will undergo each of these during different pacemaker settings. These are: 1) No pacing, 2) Paced from the right ventricular lead; 3) Paced from the left ventricular lead and 4) Paced from both ventricular leads. After this has been done the participants involvement in the study will have finished. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients attending follow up clinic with a CRT device implanted.
- Patients have to be receiving CRT therapy - in other words, the device has to be functioning correctly.
- Aged 18 or over.
- The patient has been informed of the nature of the study and has provided full written informed consent.
Key exclusion criteria (1 listed)
- Patients unable to give informed consent including those with communication difficulties due to poor English.
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 |
|---|---|---|
| Cardiogoniometry | Device | Cardiogoniometry (CGM) |
Primary outcome
Mean cardiac axis with no pacing
Time frame: Within the first 30 days after end of participant enrollment
Mean cardiac axis of participants when they are not being paced will be calculated with 95% confidence intervals.
Mean cardiac axis with rv pacing
Time frame: Within the first 30 days after end of participant enrollment
Mean cardiac axis of participants when they are being paced from the RV will be calculated with 95% confidence intervals.
Mean cardiac axis with lv pacing
Time frame: Within the first 30 days after end of participant enrollment
Mean cardiac axis of participants when they are being paced from the LV will be calculated with 95% confidence intervals.
Mean cardiac axis with biv pacing
Time frame: Within the first 30 days after end of participant enrollment
Mean cardiac axis of participants when they are being biventricular paced will be calculated with 95% confidence intervals.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Background: PubMed 29989935Brown OI, Nikolaidou T, Beddoes G, Hoye A, Clark AL. The HF-CGM Study: An Analysis of Cardiogoniometric Axes in Patients With Cardiac Resynchronization Therapy. IEEE Trans Biomed Eng. 2018 Aug;65(8):1711-1716. doi: 10.1109/TBME.2017.2769060. Epub 2017 Nov 2.
- Abstract LinkLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiogoniometry in people with Heart Failure, run by Hull University Teaching Hospitals NHS Trust at 1 site 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 1 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: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cardiac axis with no pacing (time frame: Within the first 30 days after end of participant enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803879, which also lists 1 linked publication.
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 8 Jul 2019.