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

Not yet recruiting

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

• Registration Number: NCT07014579
• Lead Sponsor: University of Leicester

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. 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

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Glenfield Hospital; 🇬🇧 Leicester, Leicestershire, United Kingdom