The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

— DCM-MSF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026112
• Other study ID #: 143656
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2022
• Source: University College, London
• Contact: Fiona Chan, MBBS
• Phone: 02076705702
• Email: f.chan[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Diagnostic Test:
• ECG-Imaging
ECG imaging acquisition
• Cardiac MRI scan
Cardiac MRI scan

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital NHS Trust (RFH)	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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).	2 years
Secondary	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)	2 years
Secondary	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	2 years