Paroxysmal Atrial FibrillationNCT03305744
Atrial Electromechanical Function in Endurance Athletes With and Without Atrial Fibrillation
An observational study of Paroxysmal Atrial Fibrillation, run by University of Toronto at 1 site in Canada.
Trial summary
This study evaluates cardiac structure and function differences between healthy endurance trained athletes with atrial fibrillation and healthy age matched endurance trained athletes without atrial fibrillation. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2018to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample from, but not limited to, various running, cycling, and rowing clubs for middle-aged athletes. Healthy endurance athletes will be selected from an existing study for convenience (non-probability sample). Endurance athletes with AF will be selected from the community (probability sample).
Who may be able to join
- ALL participants:
- endurance athlete (cyclist, runner, triathlete or other) who participate in vigorous year-round training of 4-6 hours per week for a minimum of 20 years
- participation in atleast one major competition per year (marathon/triathlon/endurance competition)
- sinus rhythm during all assessments
- diagnosed with lone paroxysmal AF in the last 4 years
- able to verify diagnosis (ECG or Holter verification/proof of diagnosis),
Show all 10Show fewer
- can be on any type of medication.
- Inclusion criteria specific to healthy endurance athletes without AF:
- previous participation in Athlete's Heart Study
- has completed resting cardiac magnetic resonance imaging and resting electrocardiogram
Who cannot join
- females
- no more than >1 hour per week of resistance training
- treatment or prior diagnosis of cardiovascular disease, valvular disease, hypertension, heart failure, diabetes, thyroid disorder, sleep apnea, current/recent viral disease, chronic inflammatory disease
- previous (within 10 years) or current smoking
- recreational drug use or alcohol consumption in excess of accepted standards
- inability to provide informed consent
- inability to verify AF diagnosis (if AF athlete).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atrial Electromechanical Function in Middle-aged Endurance Athletes With and Without Atrial Fibrillation
This study evaluates cardiac structure and function differences between healthy endurance trained athletes with atrial fibrillation and healthy age matched endurance trained athletes without atrial fibrillation. It is hypothesized that despite having similar structural adaptations of the heart (due to endurance training), athletes with atrial fibrillation display will impaired heart functional measures compared to endurance athletes without atrial fibrillation.
Read the detailed description
Regular physical activity, including vigorous exercise, lowers cardiovascular risk factors, including the risk of developing Atrial Fibrillation (AF), one of the most commonly diagnosed types of arrhythmias. Paradoxically, despite the cardioprotective effects of exercise, middle aged endurance athletes are at 5 fold risk of developing AF compared to active individuals. Long standing endurance training induces significant changes to the heart- collectively known as the 'athlete's heart.' While these changes may be beneficial for performance, they may be conducive in promoting the risk of AF in this cohort. The aim of this study is to compare cardiac structure and function in endurance athletes diagnosed with AF (n=17) and in healthy aged matched endurance athletes (n=17). Male subjects between ages 45 and 65 years old with a long-standing history of endurance training and competition will be recruited. Heart structure and function will be compared at rest and during submaximal exercise. Participants will also complete fitness assessments and questionnaires that characterize their lifetime involvement in exercise training. This study will address the gap in the literature regarding the interaction of endurance training and AF risk.
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Athlete, Middle-aged, Endurance training, Cardiac Function, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
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 |
|---|---|---|
| Endurance Athlete with Atrial Fibrillation | These are middle-aged athletes who are diagnosed with paroxysmal Atrial Fibrillation in the last 4 years, but are otherwise free of disease. | |
| Endurance Athlete without Atrial Fibrillation | These are middle-aged athletes who will serve as our control group- they have not been diagnosed with AF or any other disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left intra-atrial electromechanical delay (ms)
Left intra-atrial electromechanical delay will be measured using cardiac echocardiography at rest and during submaximal cycling. Left intra-atrial electromechanical delay will be measured as the time interval between the initiation of the P wave (on an electrocardiogram) to the beginning of the late diastolic wave (Am wave) on echocardiography.
Measured: baseline (day 1: at first visit, one time measure)
Secondary outcomes (2)
Left atrial reservoir function
Left atrial reservoir function will be measured by Speckle Tracking echocardiography, at 60-80 frames per second. Left atrial reservoir function will be measured by assessing left atrial reservoir strain (%), measured during ventricular systole on echocardiography.
Measured: baseline (day 1: at first visit, one time measure)
Left atrial volume (mL)
Left atrial volume (mL) will be measured using echocardiography at the end of ventricular systole, prior to the opening of the mitral valve. Imaging will be acquired using two and four chamber views.
Measured: baseline (day 1: at first visit, one time measure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start30 Jan 2018
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Emily Vecchiarelli, University of Toronto
- Investigators
- Emily Vecchiarelli, BKin, Principal investigator, University of TorontoJack Goodman, PhD, Principal investigator, University of TorontoPaul Dorian, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305744
- Sponsor's protocol ID
- AthletesHeartUofT
- Status last verified
- Nov 2020
- First submitted
- 29 Sep 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participant data may be used for future study upon participant consent for their de-identified data to be used in the event that a related study is conducted. Only principal investigators will have access to records and will have the ability to share data with approved researchers.
Publications
Molina L, Mont L, Marrugat J, Berruezo A, Brugada J, Bruguera J, Rebato C, Elosua R. Long-term endurance sport practice increases the incidence of lone atrial fibrillation in men: a follow-up study. Europace. 2008 May;10(5):618-23. doi: 10.1093/europace/eun071. Epub 2008 Apr 4.
PubMed 18390875Grimsmo J, Grundvold I, Maehlum S, Arnesen H. High prevalence of atrial fibrillation in long-term endurance cross-country skiers: echocardiographic findings and possible predictors--a 28-30 years follow-up study. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):100-5. doi: 10.1097/HJR.0b013e32833226be.
PubMed 20065854Calvo N, Brugada J, Sitges M, Mont L. Atrial fibrillation and atrial flutter in athletes. Br J Sports Med. 2012 Nov;46 Suppl 1:i37-43. doi: 10.1136/bjsports-2012-091171.
PubMed 23097477
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Electromechanical Function in Middle-aged Endurance Athletes With and Without Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03305744
- Acronym / sponsor ID
- AthletesHeartUofT
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Athlete, Middle-aged, Endurance training, Cardiac Function, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 10 Oct 2017 (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.
This study evaluates cardiac structure and function differences between healthy endurance trained athletes with atrial fibrillation and healthy age matched endurance trained athletes without atrial fibrillation. It is hypothesized that despite having similar structural adaptations of the heart (due to endurance training), athletes with atrial fibrillation display will impaired heart functional measures compared to endurance athletes without atrial fibrillation.
Detailed description
Regular physical activity, including vigorous exercise, lowers cardiovascular risk factors, including the risk of developing Atrial Fibrillation (AF), one of the most commonly diagnosed types of arrhythmias. Paradoxically, despite the cardioprotective effects of exercise, middle aged endurance athletes are at 5 fold risk of developing AF compared to active individuals. Long standing endurance training induces significant changes to the heart- collectively known as the 'athlete's heart.' While these changes may be beneficial for performance, they may be conducive in promoting the risk of AF in this cohort. The aim of this study is to compare cardiac structure and function in endurance athletes diagnosed with AF (n=17) and in healthy aged matched endurance athletes (n=17). Male subjects between ages 45 and 65 years old with a long-standing history of endurance training and competition will be recruited. Heart structure and function will be compared at rest and during submaximal exercise. Participants will also complete fitness assessments and questionnaires that characterize their lifetime involvement in exercise training. This study will address the gap in the literature regarding the interaction of endurance training and AF risk.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance Athlete with Atrial Fibrillation | – | –These are middle-aged athletes who are diagnosed with paroxysmal Atrial Fibrillation in the last 4 years, but are otherwise free of disease. |
| Endurance Athlete without Atrial Fibrillation | – | –These are middle-aged athletes who will serve as our control group- they have not been diagnosed with AF or any other disease. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample from, but not limited to, various running, cycling, and rowing clubs for middle-aged athletes. Healthy endurance athletes will be selected from an existing study for convenience (non-probability sample). Endurance athletes with AF will be selected from the community (probability sample).
Key inclusion criteria (10 listed)
- endurance athlete (cyclist, runner, triathlete or other) who participate in vigorous year-round training of 4-6 hours per week for a minimum of 20 years
- participation in atleast one major competition per year (marathon/triathlon/endurance competition)
- sinus rhythm during all assessments
- diagnosed with lone paroxysmal AF in the last 4 years
- able to verify diagnosis (ECG or Holter verification/proof of diagnosis),
Key exclusion criteria (7 listed)
- females
- no more than >1 hour per week of resistance training
- treatment or prior diagnosis of cardiovascular disease, valvular disease, hypertension, heart failure, diabetes, thyroid disorder, sleep apnea, current/recent viral disease, chronic inflammatory disease
- previous (within 10 years) or current smoking
- recreational drug use or alcohol consumption in excess of accepted standards
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
Left intra-atrial electromechanical delay (ms)
Time frame: baseline (day 1: at first visit, one time measure)
Left intra-atrial electromechanical delay will be measured using cardiac echocardiography at rest and during submaximal cycling. Left intra-atrial electromechanical delay will be measured as the time interval between the initiation of the P wave (on an electrocardiogram) to the beginning of the late diastolic wave (Am wave) on echocardiography.
2 secondary outcomes
Left atrial reservoir function
Time frame: baseline (day 1: at first visit, one time measure)
Left atrial volume (mL)
Time frame: baseline (day 1: at first visit, one time measure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 18390875Molina L, Mont L, Marrugat J, Berruezo A, Brugada J, Bruguera J, Rebato C, Elosua R. Long-term endurance sport practice increases the incidence of lone atrial fibrillation in men: a follow-up study. Europace. 2008 May;10(5):618-23. doi: 10.1093/europace/eun071. Epub 2008 Apr 4.
- Background: PubMed 20065854Grimsmo J, Grundvold I, Maehlum S, Arnesen H. High prevalence of atrial fibrillation in long-term endurance cross-country skiers: echocardiographic findings and possible predictors--a 28-30 years follow-up study. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):100-5. doi: 10.1097/HJR.0b013e32833226be.
- Background: PubMed 23097477Calvo N, Brugada J, Sitges M, Mont L. Atrial fibrillation and atrial flutter in athletes. Br J Sports Med. 2012 Nov;46 Suppl 1:i37-43. doi: 10.1136/bjsports-2012-091171.
- Individual participant dataSharing planned: Undecided. Participant data may be used for future study upon participant consent for their de-identified data to be used in the event that a related study is conducted. Only principal investigators will have access to records and will have the ability to share data with approved researchers.
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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. This study is not recruiting at the moment.
Emily Vecchiarelli, BKin principal investigator
University of Toronto
Jack Goodman, PhD principal investigator
University of Toronto
Paul Dorian, MD principal investigator
Unity Health Toronto
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 Paroxysmal Atrial Fibrillation, run by University of Toronto at 1 site in Canada.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Nov 2020. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left intra-atrial electromechanical delay (ms) (time frame: baseline (day 1: at first visit, one time measure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03305744, which also lists 3 linked publications.
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 3 Nov 2020; AzTrials last refreshed its copy on 30 Oct 2026.