Understanding the Increased Risk of Atrial Fibrillation in Athletes: a Case-control Study (AFLETES-ECG)

February 21, 2025 updated by: University of Leicester

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Leicester, United Kingdom, LE3 9QP
        • Department of Cardiovascular Sciences. University of Leicester. Glenfield Hospital.
        • Contact:
        • Principal Investigator:
          • Andre Ng, Professor
        • Principal Investigator:
          • Gerry McCann, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • ≥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:

    1. Competed in endurance sports with a total cumulative moderate to high intensity of > 1500 hours.
    2. Have participated in at least one competitive event in the last 10 years.

Exclusion Criteria:

  • Permanent atrial fibrillation.

  • History of pre-existing cardiovascular disease :

    1. Atherosclerotic disease: previous myocardial infarction, symptomatic coronary artery disease or Peripheral peripheral arterial disease
    2. Left ventricular systolic dysfunction (EF < 45%)
    3. Heart muscle disease: cardiomyopathies, Infiltrative diseases of the heart
    4. Complex Congenital heart disease
    5. Moderate or severe valvular disease
    6. Uncontrolled hypertension (>180/100mmHg)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
AF Athletes
Athletes with atrial fibrillation.
Non-AF Athletes
Athletes without atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
High-resolution ECG
Time Frame: At study visit

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AI classification and prediction
Time Frame: At study visit

Assess the accuracy of using machine learning to identify athletes with AF using ECG data.

AUC, specificity and sensitivity of machine learning identification of AF.
At study visit
72hr heart rate monitoring
Time Frame: At study visit

Compare autonomic tone via heart rate variability from 72-hour continuous ECG monitoring in athletes with and without AF.

Analysis of RR intervals from heart rate variability.
At study visit
Electronic stethoscope recording
Time Frame: At study visit

Compare the heart sounds using electronic stethoscope in athletes with and without AF.

S1 and S2 sounds of heart valves.
At study visit
Cardiac imaging
Time Frame: At study visit
Left ventricular mass
At study visit
Cardiac imaging
Time Frame: At study visit
Left ventricular volume
At study visit
Cardiac imaging
Time Frame: At study visit
Strain rate
At study visit
Cardiac imaging
Time Frame: At study visit
Myocardial perfusion reserve
At study visit
Cardiac imaging
Time Frame: At study visit
Myocardial interstitial fibrosis
At study visit
Cardiac imaging
Time Frame: At study visit
Left atrial mass
At study visit
Cardiac imaging
Time Frame: At study visit
Left atrial volume
At study visit
Cardiac imaging
Time Frame: At study visit
Vascular stiffness
At study visit
Cardiac imaging
Time Frame: At study visit
Left ventricular filling pressure
At study visit
Cardiac imaging
Time Frame: At study visit
Tissue Doppler velocity
At study visit
Cardiopulmonary exercise testing
Time Frame: At study visit
Peak VO2
At study visit
Cardiopulmonary exercise testing
Time Frame: At study visit
Exercising p wave duration
At study visit
Cardiopulmonary exercise testing
Time Frame: At study visit
Exercising p wave amplitude
At study visit
Cardiopulmonary exercise testing
Time Frame: At study visit
Exercising p wave dispersion
At study visit
Cardiopulmonary exercise testing
Time Frame: At study visit
Exercising p wave PTFV1
At study visit
Cardiac motion recording
Time Frame: At study visit
Cardiac angular velocity
At study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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