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Search / Trial NCT07014579

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

Launched by UNIVERSITY OF LEICESTER · Jun 9, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Ultimate Athlete Life Map R2 I2 Pers Ventricular Arrhythmia Ventricular Fibrillation Sudden Cardiac Death

ClinConnect Summary

This clinical trial is looking to understand how certain patterns in heart electrical signals can help identify athletes who may be at risk for dangerous heart rhythms, such as sudden cardiac arrest. The researchers want to see if two specific markers (R2I2 and PERS) can help find athletes at higher risk and if exercise tests can provide the same information as more invasive hospital procedures. Participants will include active individuals aged 18 and older, especially those who regularly exercise for at least three hours a week. Athletes with implanted heart devices like defibrillators or pacemakers will be compared to those without these devices.

If you decide to participate, you can expect to undergo several heart monitoring tests, including ECG recordings while resting and exercising, and a continuous 24-hour ECG. The study is not yet recruiting participants, but it's important to know that you won't be eligible if you're pregnant, have certain heart conditions, or are unable to follow the study's protocols. This research aims to improve how we detect and prevent serious heart issues in athletes, making it a meaningful opportunity for those who qualify.

Gender

ALL

Eligibility criteria

  • 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

About University Of Leicester

The University of Leicester is a leading research institution in the UK, renowned for its commitment to advancing scientific knowledge and improving healthcare through innovative clinical trials. The university fosters a collaborative environment that integrates diverse disciplines, enabling the development of cutting-edge research initiatives aimed at addressing pressing medical challenges. With a focus on ethical practices and patient-centered outcomes, the University of Leicester is dedicated to enhancing clinical research methodologies and contributing to the advancement of medical sciences, ultimately striving to translate research findings into tangible health benefits for communities.

Locations

Leicester, Leicestershire, United Kingdom

Patients applied

0 patients applied

Trial Officials

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

Study Director

University of Leicester, Leicestershire, United Kingdom

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

Principal Investigator

University of Leicester, Leicestershire, United Kingdom

Xin Li, PhD, MSc, BSc, FHEA

Principal Investigator

University of Leicester, Leicestershire, United Kingdom

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

Principal Investigator

Glenfield Hospital, Leicester

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported