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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-07-31

Brief Summary

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The goal of this observational study is to learn if two specific heart electrical signal patterns can help in detecting the risk of dangerous heart rhythms in athletes, and to see if exercise-based tests can be used instead of invasive hospital procedures to record this electrical signals.

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.

Detailed Description

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Conditions

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Inherited Cardiac Conditions Sudden Cardiac Arrest Ventricular Arrhythmia Athlete Ventricular Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Age 18 and over.
* 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

* Pregnancy, as detected by positive urine pregnancy test result.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

Central Contacts

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Abdulmalik I Koya, MD

Role: CONTACT

+4407990290755

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.

Reference Type BACKGROUND
PMID: 33336815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29684162 (View on PubMed)

Related Links

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https://life-map.co.uk/

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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