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Birkebeiner II Study

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ClinicalTrials.gov Identifier: NCT03741491
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Extrastiftelsen
Information provided by (Responsible Party):
Marit Aarønæs, Diakonhjemmet Hospital

Tracking Information
First Submitted Date November 2, 2018
First Posted Date November 15, 2018
Last Update Posted Date February 19, 2019
Actual Study Start Date January 21, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 11, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03741491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 11, 2018)
  • Changes in right ventricular volumes (ml) in veteran endurance athletes [ Time Frame: Cross sectional study. Measured at time for inclusion. ]
    Measured by 2D echocardiography
  • 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.
  • 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
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Birkebeiner II Study
Official Title Birkebeiner II Study Investigating the Mechanisms of Atrial Fibrillation in Elderly Performing Endurance Training
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples for DNA analysis and inflammation markers, Electronic ECG, Holter monitoring, Echocardiography
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.
Condition Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts
  • 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.
  • 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
  • Control with AF
    Persons included in HELMILO 2009 (Health and Environment Study in Oslo 2009), born 1960 and earlier with AF
  • Control without AF
    Persons included in HELMILO 2009 (Health and Environment Study in Oslo 2009), born 1960 and earlier without AF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 11, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
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%
Sex/Gender
Sexes Eligible for Study: All
Ages 58 Years to 83 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marit Aaronaes, MD,Phd +4791100777 marit.aaronaes@diakonsyk.no
Contact: Eivind Sorensen, MD +4799737439 eivind.sorensen@diakonsyk.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03741491
Other Study ID Numbers 2018/FO197570
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Marit Aarønæs, Diakonhjemmet Hospital
Study Sponsor Diakonhjemmet Hospital
Collaborators Extrastiftelsen
Investigators
Principal Investigator: Marit Aaronaes, MD,PhD Diakonhjemmet Hospital
PRS Account Diakonhjemmet Hospital
Verification Date February 2019