Electrophysiological Remodelling Secondary to Metabolic, Inflammatory and Cardiomyopathic Processes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational

Obesity, rheumatoid arthritis (RA) and gene-specific dilated cardiomyopathy (DCM) are common medical conditions. Small-scale studies have shown that these are associated with proarrhythmic changes on 12-lead electrocardiogram (ECG) and a higher risk of sudden cardiac death (SCD). However, these studies lack the deep electrophysiological phenotyping required to explain their observations. Electrocardiographic imaging (ECGi) is a non-invasive alternative to 12-lead ECG, by which epicardial potentials, electrograms and activation sequences can be recorded to study adverse electrophysiological modelling in greater depth and on a more focussed, subject-specific scale. Therefore, this study proposes to better define the risk of arrhythmia and understand the underlying adverse electrophysiological remodelling conferring this risk in three groups (obesity, RA and DCM). Firstly, data from two large, national repositories will be analysed to identify associations between routine clinical biomarkers and proarrhythmic 12-lead ECG parameters, to confirm adverse electrophysiological remodelling and a higher risk of arrhythmia. Secondly,ECGi will be performed before and after planned clinical intervention in obese and RA patients, and at baseline in titin-truncating variant (TTNtv)-positive and -negative DCM patients, to characterise the specific and potentially reversible conduction and repolarisation abnormalities that may underlie increased arrhythmic risk.

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: Accepts Healthy Volunteers

• patients with obesity (BMI>40) who will undergo stapled bariatric surgery

• RA, prior to commencement of disease-modifying drugs

• TTNtv-positive or -negative DCM

• no known existing medical condition or health concerns i.e. healthy volunteers;

• aged 18 to 75 years, inclusive

Other Locations
United Kingdom
Imperial College London (Hammersmith campus)
St Mary's Hospital
Contact Information
Fu Siong Ng, BSc MRCP PhD
Kiran HK Patel, BSc MRCP
Time Frame
Start Date: November 21, 2019
Estimated Completion Date: December 31, 2021
Target number of participants: 100
Patients with BMI >40 awaiting stapled bariatric surgery, without a history of or concomitant ischaemic or structural heart disease, arrhythmia or receiving anti-arrhythmic medication, will be recruited prospectively from the bariatric surgery preoperative assessment clinics.
Rheumatoid arthritis
Patients with RA without diagnosed or known ischaemic or structural heart disease, arrhythmia or receiving anti-arrhythmic medication will be recruited prospectively from rheumatology clinics, prior to initiation of biologic or diseased modifying anti-rheumatic drugs.
Dilated cardiomyopathy
TTNtv-positive and -negative DCM patients from the Royal Brompton Hospital biobank have provided informed consent to be contacted for research
Leads: Imperial College London
Collaborators: University College, London

This content was sourced from clinicaltrials.gov

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