Electrophysiological Phenotyping Of Patients at Risk of Ventricular Arrhythmia and Sudden Cardiac Death

NCT03910725 | Unknown

• 1 other identifier: 19HH4965
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Arrhythmia; Sudden Cardiac Death; Cardiomyopathy, Dilated; Obesity; Inflammation

Keywords

Arrhythmia; Cardiomyopathy, Dilated; Electrocardiographic imaging

Outcome Measures

Primary Outcomes (2)

• Activation-recovery intervals

  Electrocardiographic parameter

  30 months approximately ie at the end of the study

• Conduction velocity

  Electrocardiographic parameter

  30 months approximately ie at the end of the study

Study Arms (3)

Obesity

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.

Other: Electrocardiographic imaging

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.

Other: Electrocardiographic imaging

Dilated cardiomyopathy

TTNtv-positive and -negative DCM patients from the Royal Brompton Hospital biobank have provided informed consent to be contacted for research

Other: Electrocardiographic imaging

Interventions

Electrocardiographic imaging OTHER

ECGi is a non-invasive body surface mapping technique that collects electrocardiographic data using 252 leads, and combines it with subject specific anatomic data acquired from cross sectional imaging to recreate epicardial electrograms.

Dilated cardiomyopathy; Obesity; Rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 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. Similarly, patients with RA will be recruited prospectively from rheumatology clinics, prior to initiation of biologic or diseased modifying anti-rheumatic drugs. TTNtv-positive and -negative DCM patients an existing data registry will be recalled for this study. Healthy volunteers: will be recruited from our affiliated institutions who have given prior consent to be contacted for research.

You may qualify if:

• 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

You may not qualify if:

• aged under 18 or over 75 years;
• known HIV, hepatitis B \& C or vCJD infection;
• unable to provide verbal or signed written informed consent;
• pregnancy or positive urinary pregnancy test;
• breastfeeding

Sponsors & Collaborators

• Imperial College London: lead
• University College, London: collaborator

Study Sites (2)

Imperial College London (Hammersmith campus)

London, W12 0NN, United Kingdom

RECRUITING

St Mary's Hospital

London, W2 1NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Death, Sudden, Cardiac; Cardiomyopathy, Dilated; Obesity; Inflammation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Fu Siong Ng

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu Siong Ng, BSc MRCP PhD

CONTACT

+442075943614; f.ng@imperial.ac.uk

Kiran HK Patel, BSc MRCP

CONTACT

07563225319; kiran.patel@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: November 21, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)