Atrial FibrillationNCT03741491
Birkebeiner II Study
An observational study of Atrial Fibrillation, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 58 to 83 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 395 participants
- Where
- 1 siteNorway
- Study dates
- 21 Jan 2019to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 58 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Already included in the Birkebeiner studies or "Health and environment study in Oslo" (HELMILO)
- Born 1960 and earlier
Who cannot join
- Born before 1935.
- Earlier heart valve surgery.
- MI (Mitral Insufficiency)≥ grade 3
- Ejection Fraction (EF) <35%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Birkebeiner II Study Investigating the Mechanisms of Atrial Fibrillation in Elderly Performing Endurance Training
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes
Volume changes (ml) in the three phases of atrial function, measured by triplane echocardiography.
Measured: Cross sectional study. Measured at time for inclusion.
Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes
2D strain (%) in the three phases of atrial function, measured by triplane echocardiography.
Measured: Cross sectional study. Measured at time for inclusion.
Secondary outcomes (6)
Changes in right ventricular volumes (ml) in veteran endurance athletes
Measured by 2D echocardiography
Measured: Cross sectional study. Measured at time for inclusion.
Changes in p-wave (p-wave duration (msec), morphology and axis) in veteran endurance athletes
Measured by ECG derived vector cardiograms.
Measured: Cross sectional study. Measured at time for inclusion.
Changes in R-R variability (msec) in veteran endurance athletes
Measured by Holter ECG recordings
Measured: Cross sectional study. Measured at time for inclusion.
Presence of 171 genetic variants known to be associated with atrial fibrillation in veteran endurance athletes.
Measured by genome-wide genotyping and next generation sequencing in the combination with Sanger sequencing.
Measured: Cross sectional study. Measured at time for inclusion.
Changes in biochemical markers associated with atrial fibrosis and inflammation in veteran endurance athletes.
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
Measured: Cross sectional study. Measured at time for inclusion.
European Heart Rhythm Association (EHRA) score of atrial fibrillation related symptoms in veteran endurance athletes.
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.
Measured: Cross sectional study. Measured at time for inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start21 Jan 2019
- Primary completion11 Nov 2020
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Extrastiftelsen
- Responsible party
- Principal investigator, Marit Aarønæs, Diakonhjemmet Hospital
- Investigators
- Marit Aaronaes, MD,PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741491
- Sponsor's protocol ID
- 2018/FO197570
- Status last verified
- Feb 2023
- First submitted
- 2 Nov 2018
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birkebeiner II Study Investigating the Mechanisms of Atrial Fibrillation in Elderly Performing Endurance Training
- ClinicalTrials.gov ID
- NCT03741491
- Acronym / sponsor ID
- 2018/FO197570
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Extrastiftelsen
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 58 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Already included in the Birkebeiner studies or "Health and environment study in Oslo" (HELMILO)
- Born 1960 and earlier
Key exclusion criteria (4 listed)
- Born before 1935.
- Earlier heart valve surgery.
- MI (Mitral Insufficiency)≥ grade 3
- Ejection Fraction (EF) <35%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Changes in right ventricular volumes (ml) in veteran endurance athletes
Time frame: Cross sectional study. Measured at time for inclusion.
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.
Changes in R-R variability (msec) in veteran endurance athletes
Time frame: Cross sectional study. Measured at time for inclusion.
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.
Changes in biochemical markers associated with atrial fibrosis and inflammation in veteran endurance athletes.
Time frame: Cross sectional study. Measured at time for inclusion.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marit Aaronaes, MD,PhD principal investigator
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in atrial function and presence of atrial fibrillation in veteran endurance athletes (time frame: Cross sectional study. Measured at time for inclusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.