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The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy

The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy: a Combined ECGI and CMR Investigative Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05026112
Acronym
DCM-MSF
Enrollment
120
Registered
2021-08-30
Start date
2021-10-01
Completion date
2024-10-01
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTECG-Imaging

ECG imaging acquisition

DIAGNOSTIC_TESTCardiac MRI scan

Cardiac MRI scan

Sponsors

University College, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adults with dilated cardiomyopathy * With and without midwall septal fibrosis on previous CMR

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
The relationship between the electrical and structural substrate in DCM2 yearsThe investigators will describe the relationship between the electrical and structural substrate in DCM across the spectrum of left ventricular dysfunction.

Secondary

MeasureTime frameDescription
Comparison of epicardial activation and conduction patterns via ECGI2 yearsThe investigators will compare participants with MSF+DCM, MSF-DCM and controls in terms of epicardial activation and conduction patterns (via ECGI).
Comparison of MSF+DCM, MSF-DCM and controls' electromechanical function of the heart via modelling2 yearsThe investigators will compare MSF+DCM, MSF-DCM and controls in terms of Electromechanical function of the heart (via 4-dimensional computational models)
Personalised simulation of risk of malignant ventricular arrhythmia2 yearsApplying 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

Countries

United Kingdom

Contacts

Primary ContactFiona Chan, MBBS
f.chan@ucl.ac.uk02076705702
Backup ContactGabriella Captur, PhD
gabriella.captur@ucl.ac.uk02076705702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026