- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03741491
Birkebeiner II Study
Birkebeiner II Study Investigating the Mechanisms of Atrial Fibrillation in Elderly Performing Endurance Training
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Marit Aaronaes, MD,Phd
- Phone Number: +4791100777
- Email: marit.aaronaes@diakonsyk.no
Study Contact Backup
- Name: Eivind Sorensen, MD
- Phone Number: +4799737439
- Email: eivind.sorensen@diakonsyk.no
Study Locations
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Oslo, Norway
- Diakonhjemmet Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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%
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Birkebeiner with AF
Persons already included in the Birkebeiner Aging Study (BIAS) (completed the Birkebeiner cross-country ski race in 2009/10 born 1945 and earlier) and BAF-study (completed the Birkebeiner cross-country ski race in 1999 and was born in 1960 and earlier) with AF.
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Birkebeiner without AF
Persons already included in the Birkebeiner Aging Study (BIAS) (completed the Birkebeiner cross-country ski race in 2009/10 born 1945 and earlier) and BAF-study (completed the Birkebeiner cross-country ski race in 1999 and was born in 1960 and earlier) without AF
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Control with AF
Persons included in HELMILO 2009 (Health and Environment Study in Oslo 2009), born 1960 and earlier with AF
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Control without AF
Persons included in HELMILO 2009 (Health and Environment Study in Oslo 2009), born 1960 and earlier without AF
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes
Time Frame: Cross sectional study. Measured at time for inclusion.
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Volume changes (ml) in the three phases of atrial function, measured by triplane echocardiography.
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Cross sectional study. Measured at time for inclusion.
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Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes
Time Frame: Cross sectional study. Measured at time for inclusion.
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2D strain (%) in the three phases of atrial function, measured by triplane echocardiography.
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Cross sectional study. Measured at time for inclusion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in right ventricular volumes (ml) in veteran endurance athletes
Time Frame: Cross sectional study. Measured at time for inclusion.
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Measured by 2D echocardiography
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Cross sectional study. Measured at time for inclusion.
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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.
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Measured by ECG derived vector cardiograms.
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Cross sectional study. Measured at time for inclusion.
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Changes in R-R variability (msec) in veteran endurance athletes
Time Frame: Cross sectional study. Measured at time for inclusion.
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Measured by Holter ECG recordings
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Cross sectional study. Measured at time for inclusion.
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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.
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Measured by genome-wide genotyping and next generation sequencing in the combination with Sanger sequencing.
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Cross sectional study. Measured at time for inclusion.
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Changes in biochemical markers associated with atrial fibrosis and inflammation in veteran endurance athletes.
Time Frame: Cross sectional study. Measured at time for inclusion.
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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
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Cross sectional study. Measured at time for inclusion.
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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.
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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.
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Cross sectional study. Measured at time for inclusion.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marit Aaronaes, MD,PhD, Diakonhjemmet Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/FO197570
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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