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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03305744
Other study ID # AthletesHeartUofT
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 30, 2018
Est. completion date August 2021

Study information

Verified date November 2020
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34
Est. completion date August 2021
Est. primary completion date August 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 45 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Goldring Center for High Performance Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Lifetime hours of Physical Activity (# of hours) Total lifetime hours of physical activity will be assessed using the Lifetime Physical Activity Questionnaire (LTPAQ). baseline (day 1: at first visit, one time measure)
Other Maximal oxygen consumption (VO2 max) 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. baseline (day 1: at first visit, one time measure)
Primary 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. baseline (day 1: at first visit, one time measure)
Secondary 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. baseline (day 1: at first visit, one time measure)
Secondary 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. baseline (day 1: at first visit, one time measure)
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