Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People

NCT07014579 | Not Yet Recruiting

• 2 other identifiers: 1037NIHR203327
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Can special ECG action potential duration markers (R2I2 and PERS) identify athletes who are at higher risk of sudden heart rhythm problems.
2. 2.Can an exercise test give the same information as a non-invasive electrophysiology study.
3. 3.ECG recordings during rest and exercise.
4. 4.If they have an ICD or pacemaker, an ECG will be recorded during a non invasive stimulation.
5. 5.A continuous 24 hour ECG.

Conditions

Inherited Cardiac Conditions; Sudden Cardiac Arrest; Ventricular Arrhythmia; Athlete; Ventricular Fibrillation

Keywords

ULTIMATE-Athlete; LifeMap; R2I2; PERS; Ventricular Arrhythmia; Ventricular Fibrillation; Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

• Change in Restitution Markers as Determined by R2I2 and PERS

  The primary outcome measure is assessment of changes in the regional restitution instability index and peak ECG restitution slope at various time points including, baseline, during 15-minute exercise and during 15-minute electrophysiology study.

Secondary Outcomes (1)

• Non-invasive exercise-based tests correlate with electrophysiology study.

  The secondary outcome looks at how the Regional Restitution Instability Index (R2I2) and Peak ECG restitution slope (PERS) measurements during a 15-minute exercise compare with those taken during 15 minute Non-Invasive Programmed Stimulation (NIPS).

Study Arms (3)

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.

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.

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.

Eligibility Criteria

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

Study Population

Study population will be from a single tertiary care hospital (University Hospitals Leicester), and residents of United Kingdom

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33336815 BACKGROUND

• 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.

  PMID: 29684162 BACKGROUND

Related Links

• LifeMap is a novel, highly promising technique for assessing risk of sudden cardiac death, a condition that kills 3 million people annually

MeSH Terms

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac

Study Officials

• Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP

  University of Leicester, Leicestershire, United Kingdom

  STUDY DIRECTOR

• Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP, FHEA

  University of Leicester, Leicestershire, United Kingdom

  PRINCIPAL INVESTIGATOR

• Xin Li, PhD, MSc, BSc, FHEA

  University of Leicester, Leicestershire, United Kingdom

  PRINCIPAL INVESTIGATOR

• Harshil Dhutia, MBBS, BSC, MRCP, CCDS, MD(RES)

  Glenfield Hospital, Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdulmalik I Koya, MD

CONTACT

+4407990290755; aik8@leicester.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: May 28, 2025
• First Posted: June 11, 2025
• Study Start: June 1, 2025
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

GB (1)