Hypertrophic CardiomyopathyPREDICTVFIINCT04157205
Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular Fibrillation Events In Hypertrophic Cardiomyopathy
A study testing Non-invasive ECG imaging - CardioInsight test in people with Hypertrophic Cardiomyopathy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Hypertrophic Cardiomyopathy (HCM) is an inherited heart condition. Most people who have it are unaware of any problems relating to it. Unfortunately, a small number of people with the condition can suddenly develop a dangerous fast heart beat that can lead to death. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Non-invasive ECG imaging - CardioInsight test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2019to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Does the patient have maximum wall thickness >13mm by any imaging technique? i) If so, does the patient have a first degree relative (sibling, parent, child) with a formal diagnosis of HCM -AND- ii) Does the patient have any of the following: Does the patient have any of the following: abnormal Doppler myocardial imaging or strain, incomplete systolic anterior motion, elongation of mitral valve leaflets and abnormal papillary muscles, abnormal ECG? -OR-
- Does the patient have maximum wall thickness 15mm or more by any imaging technique?
- Is the patient male or female 18-100years of age?
- High or intermediate risk for sudden cardiac death from HCM based on the ESC risk calculator predicting >4% risk over 5 years by specialist inherited cardiac disease clinic. This would use the online SCD-risk calculator
Who cannot join
- Patients with previous cardiac arrest
- Patients with haemodynamically unstable VT needing medical attention.
- Evidence of one of the following conditions causing secondary hypertrophy:
- Hypertension >200/100; Severe aortic stenosis; Anderson-Fabry disease; Myocarditis; Congenital heart disease; TTR-related amyloidosis; Myotonic dystrophy; Mitochondrial disease, Noonan syndrome, LEOPARD syndrome, Costello syndrome, Danon disease, Friedreich's ataxia, Glycogen storage disease, FHLI mutation, PRKAG2 mutations
- Patients with previous appropriate therapy from an ICD.
- Patients under the age of 18 years
Show all 13Show fewer
- Patients who are not safe to discontinue Beta blockers
- Patients unable to exercise due to musculoskeletal problems
- Patients with skin allergies to ECG gel/electrodes.
- Life expectancy shorter than the duration of the trial.
- Pregnant or planning pregnancy at the time of CT scan.
- Patients unable to consent to the study protocol or provide contact details for follow up.
- Patients currently participating in an interventional medical or device trial.
Trial locations and contacts
1 site in 1 country.
About this study
Hypertrophic Cardiomyopathy (HCM) is an inherited heart condition. Most people who have it are unaware of any problems relating to it. Unfortunately, a small number of people with the condition can suddenly develop a dangerous fast heart beat that can lead to death. There is no cure, but implanting a cardioverter-defibrillator (ICD), which is like a pacemaker can save the life of affected individuals. However, ICD implantation has its own problems, so choosing who gets an ICD is a very important decision.
The current approach for recommending people for an ICD has limitations and a better method is needed. Investigators have developed a new technique called the 'Ventricular Conduction Stability' (V-CoS). This involves wearing a special vest which records electrical signals from the heart, and then running on a treadmill. Investigators have used it to identify abnormalities in the hearts of people with HCM who have also survived a life-threatening event.
This project aims to test new tool against current methods to ascertain which is better at identifying patients who should have an ICD.
Read the detailed description
To find out how accurate V-CoS test and other ECGI metrics are, the investigator will study patients with confirmed Hypertrophic Cardiomyopathy currently thought to be high risk. They will be tested by V-CoS and have their conventional risk score worked out. Patients will be followed up currently to 5 years to check if they have had a dangerously fast heartbeat or problems with their defibrillator.
Patients will be recruited primarily from three specialist Inherited Cardiac Diseases clinics in London, but will include other centres as well.
Participants will be interviewed in clinic by our team to explain the study, answer questions and to get permission for the test. Participants can leave the study at any time - it will not affect the way the investigator treat them as patients.
Participants will spend a half day at the Cardiac Investigations unit. This day will consist of, in this order:
- Any remaining discussion of the study, the tests and the consent needed with the participant.
- Putting the sensor vest on which will be done by one of the research staff. It looks like a waistcoat with electrical connections and is secured to the patient's skin with conductive jelly underneath to help the recordings.
- A 3D 'CT' scan of the chest is done to show how the sensor vest lines up with the heart. The scan has a low radiation dose, equivalent to 6 months of natural background radiation.
- Then the participant will run on the treadmill whilst the vest is used to take recordings. The lowest V-CoS test score will be recorded from each participant and used to predict their risk.
- Participants will have the V-CoS test repeated whilst doing the Valsalva maneuver. This is when participant attempt to blow out as much air as possible from lungs, but without letting any out from mouth or nose.
- Participants with implanted pacemakers or defibrillators may undergo a test where the investigator give them extra heartbeats using their implanted device. The sensor vest will be used to take recordings. The investigator want to see if V-CoS scores can be lowered further than with exercise testing.
- Participants will have a blood test or cheek swab to send for genetic testing. Then participants will be followed up. If they have a defibrillator they will be telephoned and seen in the ICD clinic every 6 months. If they do not have a defibrillator they will get follow up by telephone every 3 months. Maximum follow up is 5 years.
The results will be looked at by independent researchers to reduce bias.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Non-invasive ECG imaging - CardioInsight test
- Keywords
- sudden cardiac arrest, defibrillator
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ECG imaging - CardioInsight testDiagnostic test
- Consent session
- Fitting of ECGi vest and CT scan of the chest
- Supervised exercise test and Valsalva maneuvre
- Programmed stimulation via ICD (selected participants)
- Blood tests - genetics
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | All patients. Single arm study Receives: Diagnostic Test: Non-invasive ECG imaging - CardioInsight test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with sudden cardiac death, or appropriate therapy from ICD for VT/VF.
Sudden cardiac death, or appropriate therapy from ICD for VT/VF follow up assessed by phone call to study participant
Measured: 5 years
Secondary outcomes (5)
Number of Participants with syncopal events of unknown cause in patients without ICDs
syncopal events of unknown cause in patients without ICDs
Measured: 5 years
Number of Participants with inappropriate therapy from ICD
inappropriate therapy from ICD
Measured: 5 years
Number of Participants with indeterminate therapy from ICD
indeterminate therapy from ICD
Measured: 5 years
Number of Participants with complications from ICD implant
complications from ICD implant
Measured: 5 years
Number of Participants with complications from performing V-CoS test
complications from performing V-CoS test
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start10 Nov 2019
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Medtronic, Barts & The London NHS Trust, Daniel Bagshaw Trust, Guy's and St Thomas' NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, University Hospital of Wales, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), The Leeds Teaching Hospitals NHS Trust, Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Prapa Kanagaratnam, FRCP, PhD, Principal investigator, Imperial College NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157205
- Sponsor's protocol ID
- 17SM4246
- Acronym
- PREDICTVFII
- Status last verified
- Apr 2025
- First submitted
- 6 Nov 2019
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Participating sites will have access to the all the anonymised clinical data after completion for subtudies.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular Fibrillation Events In Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04157205
- Acronym / sponsor ID
- PREDICTVFII / 17SM4246
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- sudden cardiac arrest, defibrillator
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Medtronic, Barts & The London NHS Trust, Daniel Bagshaw Trust, Guy's and St Thomas' NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, University Hospital of Wales, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), The Leeds Teaching Hospitals NHS Trust, Royal Free Hospital NHS Foundation Trust
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Nov 2019 (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.
Hypertrophic Cardiomyopathy (HCM) is an inherited heart condition. Most people who have it are unaware of any problems relating to it. Unfortunately, a small number of people with the condition can suddenly develop a dangerous fast heart beat that can lead to death. There is no cure, but implanting a cardioverter-defibrillator (ICD), which is like a pacemaker can save the life of affected individuals. However, ICD implantation has its own problems, so choosing who gets an ICD is a very important decision.
The current approach for recommending people for an ICD has limitations and a better method is needed. Investigators have developed a new technique called the 'Ventricular Conduction Stability' (V-CoS). This involves wearing a special vest which records electrical signals from the heart, and then running on a treadmill. Investigators have used it to identify abnormalities in the hearts of people with HCM who have also survived a life-threatening event.
This project aims to test new tool against current methods to ascertain which is better at identifying patients who should have an ICD.
Detailed description
To find out how accurate V-CoS test and other ECGI metrics are, the investigator will study patients with confirmed Hypertrophic Cardiomyopathy currently thought to be high risk. They will be tested by V-CoS and have their conventional risk score worked out. Patients will be followed up currently to 5 years to check if they have had a dangerously fast heartbeat or problems with their defibrillator.
Patients will be recruited primarily from three specialist Inherited Cardiac Diseases clinics in London, but will include other centres as well.
Participants will be interviewed in clinic by our team to explain the study, answer questions and to get permission for the test. Participants can leave the study at any time - it will not affect the way the investigator treat them as patients.
Participants will spend a half day at the Cardiac Investigations unit. This day will consist of, in this order:
- Any remaining discussion of the study, the tests and the consent needed with the participant.
- Putting the sensor vest on which will be done by one of the research staff. It looks like a waistcoat with electrical connections and is secured to the patient's skin with conductive jelly underneath to help the recordings.
- A 3D 'CT' scan of the chest is done to show how the sensor vest lines up with the heart. The scan has a low radiation dose, equivalent to 6 months of natural background radiation.
- Then the participant will run on the treadmill whilst the vest is used to take recordings. The lowest V-CoS test score will be recorded from each participant and used to predict their risk.
- Participants will have the V-CoS test repeated whilst doing the Valsalva maneuver. This is when participant attempt to blow out as much air as possible from lungs, but without letting any out from mouth or nose.
- Participants with implanted pacemakers or defibrillators may undergo a test where the investigator give them extra heartbeats using their implanted device. The sensor vest will be used to take recordings. The investigator want to see if V-CoS scores can be lowered further than with exercise testing.
- Participants will have a blood test or cheek swab to send for genetic testing. Then participants will be followed up. If they have a defibrillator they will be telephoned and seen in the ICD clinic every 6 months. If they do not have a defibrillator they will get follow up by telephone every 3 months. Maximum follow up is 5 years.
The results will be looked at by independent researchers to reduce bias.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Diagnostic Test: Non-invasive ECG imaging - CardioInsight testAll patients. Single arm study |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Does the patient have maximum wall thickness >13mm by any imaging technique? i) If so, does the patient have a first degree relative (sibling, parent, child) with a formal diagnosis of HCM -AND- ii) Does the patient have any of the following: Does the patient have any of the following: abnormal Doppler myocardial imaging or strain, incomplete systolic anterior motion, elongation of mitral valve leaflets and abnormal papillary muscles, abnormal ECG? -OR-
- Does the patient have maximum wall thickness 15mm or more by any imaging technique?
- Is the patient male or female 18-100years of age?
- High or intermediate risk for sudden cardiac death from HCM based on the ESC risk calculator predicting >4% risk over 5 years by specialist inherited cardiac disease clinic. This would use the online SCD-risk calculator
Key exclusion criteria (13 listed)
- Patients with previous cardiac arrest
- Patients with haemodynamically unstable VT needing medical attention.
- Evidence of one of the following conditions causing secondary hypertrophy:
- Patients with previous appropriate therapy from an ICD.
- Patients under the age of 18 years
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 |
|---|---|---|
| Non-invasive ECG imaging - CardioInsight test1. Consent session 2. Fitting of ECGi vest and CT scan of the chest 3. Supervised exercise test and Valsalva maneuvre 4. Programmed stimulation via ICD (selected participants) 5. Blood tests - genetics | Diagnostic test | Test arm |
Primary outcome
Number of Participants with sudden cardiac death, or appropriate therapy from ICD for VT/VF.
Time frame: 5 years
Sudden cardiac death, or appropriate therapy from ICD for VT/VF follow up assessed by phone call to study participant
5 secondary outcomes
Number of Participants with syncopal events of unknown cause in patients without ICDs
Time frame: 5 years
Number of Participants with inappropriate therapy from ICD
Time frame: 5 years
Number of Participants with indeterminate therapy from ICD
Time frame: 5 years
Number of Participants with complications from ICD implant
Time frame: 5 years
Number of Participants with complications from performing V-CoS test
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Yes. Participating sites will have access to the all the anonymised clinical data after completion for subtudies.
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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.
Prapa Kanagaratnam, FRCP, PhD principal investigator
Imperial College NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ECG imaging - CardioInsight test in people with Hypertrophic Cardiomyopathy, run by Imperial College London 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 13 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: under way, not looking for participants, as of the sponsor's last update on 2 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants with sudden cardiac death, or appropriate therapy from ICD for VT/VF. (time frame: 5 years). 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 2 May 2025.