Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People (ULTIMATE-A)

University of Leicester

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07014579

1037

NIHR203327 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 3 patient groups

Participants with ICD

Description:

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

Description:

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

Description:

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.