- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305744
Atrial Electromechanical Function in Endurance Athletes With and Without Atrial Fibrillation
November 2, 2020 updated by: Emily Vecchiarelli, University of Toronto
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
34
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 2C9
- Goldring Center for High Performance
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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
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
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).
Description
Inclusion Criteria:
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
Inclusion criteria specific to endurance athletes with AF:
- diagnosed with lone paroxysmal AF in the last 4 years
- able to verify diagnosis (ECG or Holter verification/proof of diagnosis),
- 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
Exclusion Criteria:
- 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).
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 |
|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Left intra-atrial electromechanical delay (ms)
Time Frame: baseline (day 1: at first visit, one time measure)
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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.
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baseline (day 1: at first visit, one time measure)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Left atrial reservoir function
Time Frame: baseline (day 1: at first visit, one time measure)
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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.
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baseline (day 1: at first visit, one time measure)
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Left atrial volume (mL)
Time Frame: baseline (day 1: at first visit, one time measure)
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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.
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baseline (day 1: at first visit, one time measure)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lifetime hours of Physical Activity (# of hours)
Time Frame: baseline (day 1: at first visit, one time measure)
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Total lifetime hours of physical activity will be assessed using the Lifetime Physical Activity Questionnaire (LTPAQ).
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baseline (day 1: at first visit, one time measure)
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Maximal oxygen consumption (VO2 max)
Time Frame: baseline (day 1: at first visit, one time measure)
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Maximal oxygen consumption (VO2 max) will be determined using a maximal treadmill test, in which a calibrated metabolic cart and indirect calorimetry will be used.
VO2 max will be expressed as ml/kg/min.
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baseline (day 1: at first visit, one time measure)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Dorian, MD, Unity Health Toronto
- Principal Investigator: Emily Vecchiarelli, BKin, University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Grimsmo 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.
- Calvo 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.
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 (Actual)
January 30, 2018
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
September 29, 2017
First Submitted That Met QC Criteria
October 4, 2017
First Posted (Actual)
October 10, 2017
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AthletesHeartUofT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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.
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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