Dilated CardiomyopathyDCM-MSFNCT05026112
The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy
An observational study of Dilated Cardiomyopathy, run by University College, London at 1 site in United Kingdom.
Trial summary
Midwall septal fibrosis (MSF) is a common structural abnormality in non-ischaemic dilated cardiomyopathy (DCM). Its presence is believed to increase the risk of malignant ventricular arrhythmias (VA), but the mechanism of arrhythmogenicity is not known. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- ECG-Imaging and Cardiac MRI scan
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2021to 1 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with dilated cardiomyopathy, with and without midwall septal fibrosis on previous CMR
Who may be able to join
- Adults with dilated cardiomyopathy
- With and without midwall septal fibrosis on previous CMR
Who cannot join
- Needle-phobic patients that would preclude cannulation for contrast injection and blood taking
- anyone unwilling to consent
- anyone with a conventional contraindication for CMR
- anyone with any condition precluding full participation in the study such as DCM patients with infarct-pattern LGE, or subepicardial LGE or non-septal midwall fibrosis (participants with small volume right ventricular insertion point LGE will not be excluded).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital NHS Trust (RFH)
London
Fiona Chan, MBBS, 02076705702, f.chan@ucl.ac.uk
Dr Gabriella Captur, PhD
About this study
Official title: The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy: a Combined ECGI and CMR Investigative Study
Midwall septal fibrosis (MSF) is a common structural abnormality in non-ischaemic dilated cardiomyopathy (DCM). Its presence is believed to increase the risk of malignant ventricular arrhythmias (VA), but the mechanism of arrhythmogenicity is not known. This is particularly relevant in DCM patients with MSF and mid-range left ventricular ejection fraction (LVEF) as they do not currently fulfil criteria for a primary prevention implantable cardioverter-defibrillator (ICD) insertion.
Access to the epicardium for electrical measurements of the heart can enhance the understanding of arrhythmogenicity in DCM, however direct epicardial access is invasive. Instead, the investigators will non-invasively combine high resolution 256-lead ECG imaging (ECGI) and latest generation cardiovascular magnetic resonance (CMR) to study the hearts of 60 DCM patients with and without MSF regardless of LVEF, and 60 matched healthy volunteers. The investigators recently invented the re-usable and CMR-safe SMART-ECGI vest technology for this purpose. Using supercomputers, the investigators will fuse the collected ECGI/CMR data and run electromechanical simulations of whole-heart activation to non-invasively measure each participant's personalised risk of malignant VA induction.
By panoramically mapping the DCM heart in a single beat, the investigators aim to elucidate how MSF perturbs the cardiac activation front and how this could lead to life-threatening VA. This has the potential to change the method by which cardiologists risk stratify patients with DCM.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- ECG-Imaging, Cardiac MRI scan
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG-ImagingDiagnostic test
ECG imaging acquisition
Cardiac MRI scanDiagnostic test
Cardiac MRI scan
| Study group | Role | What they receive |
|---|---|---|
| DCM with MSF (MSF+) | Patients with dilated cardiomyopathy and midwall septal fibrosis identified in a previous cardiac MRI scan Receives: Diagnostic Test: ECG-Imaging; Diagnostic Test: Cardiac MRI scan | |
| DCM without MSF (MSF-) | Patients with dilated cardiomyopathy but without midwall septal fibrosis on previous cardiac MRI scan Receives: Diagnostic Test: ECG-Imaging; Diagnostic Test: Cardiac MRI scan | |
| Control - MSF+ | Control healthy volunteers (HV) to the MSF+ cohort Receives: Diagnostic Test: ECG-Imaging; Diagnostic Test: Cardiac MRI scan | |
| Control - MSF- | Control healthy volunteers (HV) to the MSF- cohort Receives: Diagnostic Test: ECG-Imaging; Diagnostic Test: Cardiac MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between the electrical and structural substrate in DCM
The investigators will describe the relationship between the electrical and structural substrate in DCM across the spectrum of left ventricular dysfunction.
Measured: 2 years
Secondary outcomes (3)
Comparison of epicardial activation and conduction patterns via ECGI
The investigators will compare participants with MSF+DCM, MSF-DCM and controls in terms of epicardial activation and conduction patterns (via ECGI).
Measured: 2 years
Comparison of MSF+DCM, MSF-DCM and controls' electromechanical function of the heart via modelling
The investigators will compare MSF+DCM, MSF-DCM and controls in terms of Electromechanical function of the heart (via 4-dimensional computational models)
Measured: 2 years
Personalised simulation of risk of malignant ventricular arrhythmia
Applying and exploring simulation methodology to establish predictions for likely propensity to malignant VA (personalised simulations of risk) between MSF+DCM, MSF-DCM and controls groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Captur, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026112
- Sponsor's protocol ID
- 143656
- Acronym
- DCM-MSF
- Status last verified
- Mar 2022
- First submitted
- 23 Aug 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy: a Combined ECGI and CMR Investigative Study
- ClinicalTrials.gov ID
- NCT05026112
- Acronym / sponsor ID
- DCM-MSF / 143656
- Conditions
- Dilated Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 30 Aug 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.
Midwall septal fibrosis (MSF) is a common structural abnormality in non-ischaemic dilated cardiomyopathy (DCM). Its presence is believed to increase the risk of malignant ventricular arrhythmias (VA), but the mechanism of arrhythmogenicity is not known. This is particularly relevant in DCM patients with MSF and mid-range left ventricular ejection fraction (LVEF) as they do not currently fulfil criteria for a primary prevention implantable cardioverter-defibrillator (ICD) insertion.
Access to the epicardium for electrical measurements of the heart can enhance the understanding of arrhythmogenicity in DCM, however direct epicardial access is invasive. Instead, the investigators will non-invasively combine high resolution 256-lead ECG imaging (ECGI) and latest generation cardiovascular magnetic resonance (CMR) to study the hearts of 60 DCM patients with and without MSF regardless of LVEF, and 60 matched healthy volunteers. The investigators recently invented the re-usable and CMR-safe SMART-ECGI vest technology for this purpose. Using supercomputers, the investigators will fuse the collected ECGI/CMR data and run electromechanical simulations of whole-heart activation to non-invasively measure each participant's personalised risk of malignant VA induction.
By panoramically mapping the DCM heart in a single beat, the investigators aim to elucidate how MSF perturbs the cardiac activation front and how this could lead to life-threatening VA. This has the potential to change the method by which cardiologists risk stratify patients with DCM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DCM with MSF (MSF+) | – | Diagnostic Test: ECG-Imaging, Diagnostic Test: Cardiac MRI scanPatients with dilated cardiomyopathy and midwall septal fibrosis identified in a previous cardiac MRI scan |
| DCM without MSF (MSF-) | – | Diagnostic Test: ECG-Imaging, Diagnostic Test: Cardiac MRI scanPatients with dilated cardiomyopathy but without midwall septal fibrosis on previous cardiac MRI scan |
| Control - MSF+ | – | Diagnostic Test: ECG-Imaging, Diagnostic Test: Cardiac MRI scanControl healthy volunteers (HV) to the MSF+ cohort |
| Control - MSF- | – | Diagnostic Test: ECG-Imaging, Diagnostic Test: Cardiac MRI scanControl healthy volunteers (HV) to the MSF- cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dilated cardiomyopathy, with and without midwall septal fibrosis on previous CMR
Key inclusion criteria (2 listed)
- Adults with dilated cardiomyopathy
- With and without midwall septal fibrosis on previous CMR
Key exclusion criteria (4 listed)
- Needle-phobic patients that would preclude cannulation for contrast injection and blood taking
- anyone unwilling to consent
- anyone with a conventional contraindication for CMR
- anyone with any condition precluding full participation in the study such as DCM patients with infarct-pattern LGE, or subepicardial LGE or non-septal midwall fibrosis (participants with small volume right ventricular insertion point LGE will not be excluded).
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 |
|---|---|---|
| ECG-ImagingECG imaging acquisition | Diagnostic test | Control - MSF+, Control - MSF-, DCM with MSF (MSF+), DCM without MSF (MSF-) |
| Cardiac MRI scanCardiac MRI scan | Diagnostic test | Control - MSF+, Control - MSF-, DCM with MSF (MSF+), DCM without MSF (MSF-) |
Primary outcome
The relationship between the electrical and structural substrate in DCM
Time frame: 2 years
The investigators will describe the relationship between the electrical and structural substrate in DCM across the spectrum of left ventricular dysfunction.
3 secondary outcomes
Comparison of epicardial activation and conduction patterns via ECGI
Time frame: 2 years
Comparison of MSF+DCM, MSF-DCM and controls' electromechanical function of the heart via modelling
Time frame: 2 years
Personalised simulation of risk of malignant ventricular arrhythmia
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Gabriella Captur, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy, run by University 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 2 inclusion and 4 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 31 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiona Chan, MBBS (02076705702, f.chan@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between the electrical and structural substrate in DCM (time frame: 2 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 31 Mar 2022.