Atrial Fibrillation (AF)AFLETES-ECGNCT06844656
Understanding the Increased Risk of Atrial Fibrillation in Athletes: a Case-control Study
An observational study of Atrial Fibrillation (AF), run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2025to 10 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Endurance athletes with and without atrial fibrillation from across the United Kingdom. Recruitment through social media, sports clubs, and word of mouth.
Who may be able to join
- ≥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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Department of Cardiovascular Sciences. University of Leicester. Glenfield Hospital.
Leicester, LE3 9QP
Cai L Davies, +447765791818, cld43@leicester.ac.uk
Andre Ng, Professor
About this study
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.
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, Athletes, Sport, Physical Activity, Exercise, Arrhythmias
- Medical subject headings
- Atrial Fibrillation, Motor Activity, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AF Athletes | Athletes with atrial fibrillation. | |
| Non-AF Athletes | Athletes without atrial fibrillation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study visit
Secondary outcomes (19)
AI classification and prediction
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.
Measured: At study visit
72hr heart rate monitoring
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.
Measured: At study visit
Electronic stethoscope recording
Compare the heart sounds using electronic stethoscope in athletes with and without AF.
S1 and S2 sounds of heart valves.
Measured: At study visit
Cardiac imaging
Left ventricular mass
Measured: At study visit
Cardiac imaging
Left ventricular volume
Measured: At study visit
Cardiac imaging
Strain rate
Measured: At study visit
Cardiac imaging
Myocardial perfusion reserve
Measured: At study visit
Cardiac imaging
Myocardial interstitial fibrosis
Measured: At study visit
Cardiac imaging
Left atrial mass
Measured: At study visit
Cardiac imaging
Left atrial volume
Measured: At study visit
Cardiac imaging
Vascular stiffness
Measured: At study visit
Cardiac imaging
Left ventricular filling pressure
Measured: At study visit
Cardiac imaging
Tissue Doppler velocity
Measured: At study visit
Cardiopulmonary exercise testing
Peak VO2
Measured: At study visit
Cardiopulmonary exercise testing
Exercising p wave duration
Measured: At study visit
Cardiopulmonary exercise testing
Exercising p wave amplitude
Measured: At study visit
Cardiopulmonary exercise testing
Exercising p wave dispersion
Measured: At study visit
Cardiopulmonary exercise testing
Exercising p wave PTFV1
Measured: At study visit
Cardiac motion recording
Cardiac angular velocity
Measured: At study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start28 Feb 2025 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844656
- Sponsor's protocol ID
- 1001
- Acronym
- AFLETES-ECG
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant identifiable data will not be shared. Imaging scans anonymised may be shared with future potential collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Increased Risk of Atrial Fibrillation in Athletes: a Case-control Study
- ClinicalTrials.gov ID
- NCT06844656
- Acronym / sponsor ID
- AFLETES-ECG / 1001
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, Athletes, Sport, Physical Activity, Exercise, Arrhythmias
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF Athletes | – | –Athletes with atrial fibrillation. |
| Non-AF Athletes | – | –Athletes without atrial fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Endurance athletes with and without atrial fibrillation from across the United Kingdom. Recruitment through social media, sports clubs, and word of mouth.
Key inclusion criteria (5 listed)
- ≥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:
Key exclusion criteria (8 listed)
- Permanent atrial fibrillation.
- History of pre-existing cardiovascular disease :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
19 secondary outcomes
AI classification and prediction
Time frame: At study visit
72hr heart rate monitoring
Time frame: At study visit
Electronic stethoscope recording
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiac imaging
Time frame: At study visit
Cardiopulmonary exercise testing
Time frame: At study visit
Cardiopulmonary exercise testing
Time frame: At study visit
Cardiopulmonary exercise testing
Time frame: At study visit
Cardiopulmonary exercise testing
Time frame: At study visit
Cardiopulmonary exercise testing
Time frame: At study visit
Cardiac motion recording
Time frame: At study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No. Individual participant identifiable data will not be shared. Imaging scans anonymised may be shared with future potential collaborators.
Related trials for Atrial Fibrillation (AF)
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CONVERGE Post-Approval Study (PAS)
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Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cai L Davies (+447765791818, cld43@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-resolution ECG (time frame: At study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.