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The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy

NCT05026112 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Dilated Cardiomyopathy

Interventions

DIAGNOSTIC_TEST

ECG-Imaging

ECG imaging acquisition

DIAGNOSTIC_TEST

Cardiac MRI scan

Cardiac MRI scan

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Gabriella Captur, PhD · University College, London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-10-01
Completion
2024-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026112 on ClinicalTrials.gov