Birkebeiner II Study

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741491
• Other study ID #: 2018/FO197570
• Status: Completed
• Start date: January 21, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2023
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 country ski race(an indicator of prolonged endurance exercise practice) with and without AF to a not-so-trained control group.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: July 1, 2022
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 58 Years to 83 Years

Eligibility

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%

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Extrastiftelsen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Cross sectional study. Measured at time for inclusion.
Primary	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.	Cross sectional study. Measured at time for inclusion.
Secondary	Changes in right ventricular volumes (ml) in veteran endurance athletes	Measured by 2D echocardiography	Cross sectional study. Measured at time for inclusion.
Secondary	Changes in p-wave (p-wave duration (msec), morphology and axis) in veteran endurance athletes	Measured by ECG derived vector cardiograms.	Cross sectional study. Measured at time for inclusion.
Secondary	Changes in R-R variability (msec) in veteran endurance athletes	Measured by Holter ECG recordings	Cross sectional study. Measured at time for inclusion.
Secondary	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.	Cross sectional study. Measured at time for inclusion.
Secondary	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	Cross sectional study. Measured at time for inclusion.
Secondary	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.	Cross sectional study. Measured at time for inclusion.