Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Birkebeiner II Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease
Atrial Fibrillation

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Birkebeiner II Study Investigating the Mechanisms of Atrial Fibrillation in Elderly Performing Endurance Training
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood samples for DNA analysis and inflammation markers, Electronic ECG, Holter monitoring, Echocardiography


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   58 Years to 83 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741491


Contacts
Layout table for location contacts
Contact: Marit Aaronaes, MD,Phd +4791100777 marit.aaronaes@diakonsyk.no
Contact: Eivind Sorensen, MD +4799737439 eivind.sorensen@diakonsyk.no

Locations
Layout table for location information
Norway
Diakonhjemmet Hospital Recruiting
Oslo, Norway
Sponsors and Collaborators
Diakonhjemmet Hospital
Extrastiftelsen
Investigators
Layout table for investigator information
Principal Investigator: Marit Aaronaes, MD,PhD Diakonhjemmet Hospital

Layout table for additonal information
Responsible Party: Marit Aarønæs, Head of outpatient clinic, Marit Aaronaes, MD, PhD, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT03741491     History of Changes
Other Study ID Numbers: 2018/FO197570
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes