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

Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07014579

Acronym

ULTIMATE-A

Enrollment

Registered

2025-06-11

Start date

2025-06-01

Completion date

2026-07-31

Last updated

2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).

Countries

United Kingdom

Contacts

Primary ContactAbdulmalik I Koya, MD

aik8@leicester.ac.uk+4407990290755

Outcome results