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Completed

NCT Number: NCT03741491

Birkebeiner II Study

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.

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Key information

Age range

58 year–83 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diakonhjemmet Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

  1. Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes

    Time frame: Cross sectional study. Measured at time for inclusion.

    Volume changes (ml) in the three phases of atrial function, measured by triplane echocardiography.

  2. Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes

    Time frame: Cross sectional study. Measured at time for inclusion.

    2D strain (%) in the three phases of atrial function, measured by triplane echocardiography.

Secondary outcomes

  1. Changes in right ventricular volumes (ml) in veteran endurance athletes

    Time frame: Cross sectional study. Measured at time for inclusion.

    Measured by 2D echocardiography

  2. Changes in p-wave (p-wave duration (msec), morphology and axis) in veteran endurance athletes

    Time frame: Cross sectional study. Measured at time for inclusion.

    Measured by ECG derived vector cardiograms.

  3. Changes in R-R variability (msec) in veteran endurance athletes

    Time frame: Cross sectional study. Measured at time for inclusion.

    Measured by Holter ECG recordings

  4. Presence of 171 genetic variants known to be associated with atrial fibrillation in veteran endurance athletes.

    Time frame: Cross sectional study. Measured at time for inclusion.

    Measured by genome-wide genotyping and next generation sequencing in the combination with Sanger sequencing.

  5. Changes in biochemical markers associated with atrial fibrosis and inflammation in veteran endurance athletes.

    Time frame: Cross sectional study. Measured at time for inclusion.

    IL-1alfa, -1ra, -4,-6,-10, -17A, -17F, -21, -22, -23, -25, -31, -33, IFN-gamma TNF-alfa, IP-10, G-CSF, GM-CSF, MCP-1, MIP-1alfa, MIP-1beta, TIMP-1-4, MMP 1-3,7-10 and 12, measured by luminex multiplex technology

  6. European Heart Rhythm Association (EHRA) score of atrial fibrillation related symptoms in veteran endurance athletes.

    Time frame: Cross sectional study. Measured at time for inclusion.

    Measured by European Heart Rhythm Association symptom score which is a classification of AF-related symptoms. The score ranges from I-no symptoms to IV-disabling symptoms.

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • Extrastiftelsen

Registry information

Official study title

Birkebeiner II Study Investigating the Mechanisms of Atrial Fibrillation in Elderly Performing Endurance Training

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Nov 15, 2018
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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