Clinical trial NCT03741491: Birkebeiner II Study
Official title: Birkebeiner II Study Investigating the Mechanisms of Atrial Fibrillation in Elderly Performing Endurance Training
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: Extrastiftelsen
First posted: 2018-11-15
Enrollment: 395
Sex: ALL
Minimum age (years): 58
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is drawn from earlier Birkebeiner studies and the Control Group from a Health population study in Oslo (HELMILO) matched by age and gender.

Brief summary: Prolonged endurance exercise is associated with an elevated risk of atrial fibrillation (AF). The mechanisms governing this increased risk remains elusive. This study aim to detail the specific traits of elderly subjects with AF conducting endurance training by comparing elderly participators in the Birkebeiner cross country ski race(an indicator of prolonged endurance exercise practice) with and without AF to a not-so-trained control group.

Detailed description: In recent years endurance sports with high intensity and participation in competition have been increasingly popular among middle aged and older people. The Birkebeiner studies are investigations of elderly non-professional athletes (65 years or older at enrollment in 2009/10) participating in the Birkebeiner cross-country ski race. It consists of Birkebeiner Aging Study, BIAS and the Birkebeiner Atrial Fibrillation, (BAF-study). The BAF-study investigated the association between prolonged endurance sport practice and the risk of AF by comparing the cohort of veteran cross-country skiers to a control population drawn from the Health and Environment Study in Oslo (HELMILO 2009).

The main findings of the Birkebeiner study so far have been that participation in the Birkebeiner cross-country ski race (an indicator of prolonged endurance exercise practice) is associated with an elevated risk of atrial fibrillation (AF) among men ≥ 65 years, and that this risk correlates with the cumulated amount of endurance-training. Similar findings were seen amongst female athletes. This increased risk of AF was shown independent of other known significant comorbidities (such as hypertension and diabetes), indicating that endurance-training at this level itself is an independent risk factor.

Regular physical exercise is an important factor when it comes to successful ageing. However, dose-relationship of physical exercise in a longer perspective is poorly studied. Atrial fibrillation is associated with increased risk of stroke, heart failure, dementia and death.

The mechanisms governing the increased risk of AF in elderly subjects undergoing endurance-training remains elusive. This study aim to detail the specific traits of elderly subjects with AF conducting endurance-training in comparison with trained and not-so-trained control groups. Thus, generating knowledge that can form the basis for better prevention and treatment of AF in this group.

Eligibility criteria: Inclusion Criteria:

* Already included in the Birkebeiner studies or "Health and environment study in Oslo" (HELMILO)
* Born 1960 and earlier

Exclusion Criteria:

* Born before 1935.
* Earlier heart valve surgery.
* MI (Mitral Insufficiency)≥ grade 3
* Ejection Fraction (EF) \<35%

Primary outcomes:
measure: Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes
timeFrame: Cross sectional study. Measured at time for inclusion.
measure: Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes
timeFrame: Cross sectional study. Measured at time for inclusion.
Secondary outcomes:
measure: Changes in right ventricular volumes (ml) in veteran endurance athletes
timeFrame: Cross sectional study. Measured at time for inclusion.
measure: Changes in p-wave (p-wave duration (msec), morphology and axis) in veteran endurance athletes
timeFrame: Cross sectional study. Measured at time for inclusion.
measure: Changes in R-R variability (msec) in veteran endurance athletes
timeFrame: Cross sectional study. Measured at time for inclusion.
measure: Presence of 171 genetic variants known to be associated with atrial fibrillation in veteran endurance athletes.
timeFrame: Cross sectional study. Measured at time for inclusion.
measure: Changes in biochemical markers associated with atrial fibrosis and inflammation in veteran endurance athletes.
timeFrame: Cross sectional study. Measured at time for inclusion.
measure: European Heart Rhythm Association (EHRA) score of atrial fibrillation related symptoms in veteran endurance athletes.
timeFrame: Cross sectional study. Measured at time for inclusion.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Marit Aaronaes, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: