NCT06844656

Brief Summary

Exercise is beneficial to heart health, however, there appears to be a 'U' shaped relationship where too much exercise may increase the risk of an irregular heart rhythm, called atrial fibrillation. Endurance athletes may have up to a 2.5-fold higher risk of developing atrial fibrillation than non-athletic controls. The mechanisms behind this increased risk of atrial fibrillation are not the well understood. It is thought to be a mixture of enlarged heart chambers, low resting heart rate, genetic predisposition and possibly scarring in the heart. In this study, the investigators will investigate the electrical activity changes in the heart, using a high-quality electrocardiogram (ECG) and relate this to changes in the heart size measured by ultrasound and MRI. Cardiopulmonary exercise testing will determine fitness (V̇O2 max) and assess the heart's electrical activity during exercise. This will be a case-control study where athletes with and without atrial fibrillation will be recruited. The investigators hope the results of this study can improve our understanding of atrial fibrillation in athletes by associating atrial fibrillation with structural and electrical differences which may aid the prediction of future atrial fibrillation development and help guide more athlete-specific treatment pathways.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Feb 2025Oct 2026

First Submitted

Initial submission to the registry

January 27, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2026

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

January 27, 2025

Last Update Submit

February 21, 2025

Conditions

Keywords

Atrial FibrillationAthletesSportPhysical ActivityExerciseArrhythmias

Outcome Measures

Primary Outcomes (1)

  • High-resolution ECG

    Using high quality ECG, assess whether subtle differences can be detected in athletes with AF, compared to athletes without AF, and whether machine learning could predict new-onset AF. Detection of subtle differences in p wave parameters (duration, amplitude, dispersion, PTFV1) in athletes with AF compared to athletes without AF. AUC, specificity and sensitivity.

    At study visit

Secondary Outcomes (19)

  • AI classification and prediction

    At study visit

  • 72hr heart rate monitoring

    At study visit

  • Electronic stethoscope recording

    At study visit

  • Cardiac imaging

    At study visit

  • Cardiac imaging

    At study visit

  • +14 more secondary outcomes

Study Arms (2)

AF Athletes

Athletes with atrial fibrillation.

Non-AF Athletes

Athletes without atrial fibrillation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endurance athletes with and without atrial fibrillation from across the United Kingdom. Recruitment through social media, sports clubs, and word of mouth.

You may qualify if:

  • ≥18 years of age at the time of enrolment, male and female.
  • History of atrial fibrillation confirmed on ECG - either paroxysmal or persistent.
  • Competitive athlete. Defined as:
  • Competed in endurance sports with a total cumulative moderate to high intensity of \> 1500 hours.
  • Have participated in at least one competitive event in the last 10 years.

You may not qualify if:

  • Permanent atrial fibrillation.
  • History of pre-existing cardiovascular disease :
  • Atherosclerotic disease: previous myocardial infarction, symptomatic coronary artery disease or Peripheral peripheral arterial disease
  • Left ventricular systolic dysfunction (EF \< 45%)
  • Heart muscle disease: cardiomyopathies, Infiltrative diseases of the heart
  • Complex Congenital heart disease
  • Moderate or severe valvular disease
  • Uncontrolled hypertension (\>180/100mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Sciences. University of Leicester. Glenfield Hospital.

Leicester, LE3 9QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, buffycoat

MeSH Terms

Conditions

Atrial FibrillationMotor ActivityArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 25, 2025

Study Start

February 28, 2025

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

October 10, 2026

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Individual participant identifiable data will not be shared. Imaging scans anonymised may be shared with future potential collaborators.

Locations