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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Inherited Cardiac Conditions Arrhythmias, Cardiac Athlete Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Arrest Ventricular Arrhythmia Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in Restitution Markers as Determined by R2I2 and PERS

Time frame: 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

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

Time frame: 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 contacts

Contact information is provided by the study sponsor or research team.

Abdulmalik I Koya, MD

CONTACT

[email protected]

+4407990290755

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Registry information

Official study title

Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes

Acronym: ULTIMATE-A

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 11, 2025
Registry last updated: Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting