Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People
NCT ID: NCT07014579
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-06-01
2026-07-31
Brief Summary
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The main questions it aims to answer are:
1. Can special ECG action potential duration markers (R2I2 and PERS) identify athletes who are at higher risk of sudden heart rhythm problems.
2. Can an exercise test give the same information as a non-invasive electrophysiology study.
Researchers will compare athletes who have an implanted heart device (ICD) with athletes who do not, to see if there are differences in these heart signals.
Participants will undergo:
1. ECG recordings during rest and exercise.
2. If they have an ICD or pacemaker, an ECG will be recorded during a non invasive stimulation.
3. A continuous 24 hour ECG.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Participants with ICD
Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and have been identified as at risk of sudden cardiac death. Therefore have been implanted with an implantable defibrillator (ICD) for primary or secondary prevention.
No interventions assigned to this group
Participants without heart device
Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and do not have any heart condition. Therefore have not been implanted with any heart device.
No interventions assigned to this group
Participants with Pacemaker
Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and have not been identified as at risk of sudden cardiac death. Therefore do not have an implantable cardioverter defibrillator, but have been implanted with a cardiac pacemaker due to other conditions.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participates in regular physical activity for at least 3 hours or greater weekly.
* Having Implantable cardioverter defibrillator insitu (cases).
* Having a cardiac pacemaker (control).
* Having no cardiac device (control).
* Sufficient capacity and agreement to participate orally and signed written consent forms.
* Understanding of written and spoken English language.
Exclusion Criteria
* Inability to comply with study protocols.
* Any iatrogenic cardiac pathology (stents, CABG etc).
* Unstable ventricular tachycardia (\>30 seconds).
* Any unstable malignant arrhythmia.
* Fever or presence of a clinically diagnosed febrile illness
18 Years
ALL
Yes
Sponsors
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University of Leicester
OTHER
Responsible Party
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Principal Investigators
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Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP
Role: STUDY_DIRECTOR
University of Leicester, Leicestershire, United Kingdom
Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP, FHEA
Role: PRINCIPAL_INVESTIGATOR
University of Leicester, Leicestershire, United Kingdom
Xin Li, PhD, MSc, BSc, FHEA
Role: PRINCIPAL_INVESTIGATOR
University of Leicester, Leicestershire, United Kingdom
Harshil Dhutia, MBBS, BSC, MRCP, CCDS, MD(RES)
Role: PRINCIPAL_INVESTIGATOR
Glenfield Hospital, Leicester
Locations
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Glenfield Hospital
Leicester, Leicestershire, United Kingdom
Countries
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Central Contacts
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References
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Nicolson WB, Smith MI, Vali Z, Samani NJ, Ng GA. Application of two novel electrical restitution-based ECG markers of ventricular arrhythmia to patients with nonischemic cardiomyopathy. Pacing Clin Electrophysiol. 2021 Feb;44(2):284-292. doi: 10.1111/pace.14143. Epub 2021 Jan 4.
Ng GA, Mistry A, Li X, Schlindwein FS, Nicolson WB. LifeMap: towards the development of a new technology in sudden cardiac death risk stratification for clinical use. Europace. 2018 Sep 1;20(FI2):f162-f170. doi: 10.1093/europace/euy080.
Related Links
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LifeMap is a novel, highly promising technique for assessing risk of sudden cardiac death, a condition that kills 3 million people annually
Other Identifiers
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NIHR203327
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1037
Identifier Type: -
Identifier Source: org_study_id
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