NCT03741491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

November 2, 2018

Last Update Submit

February 16, 2023

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (6)

  • Changes in right ventricular volumes (ml) in veteran endurance athletes

    Cross sectional study. Measured at time for inclusion.

  • Changes in p-wave (p-wave duration (msec), morphology and axis) in veteran endurance athletes

    Cross sectional study. Measured at time for inclusion.

  • Changes in R-R variability (msec) in veteran endurance athletes

    Cross sectional study. Measured at time for inclusion.

  • Presence of 171 genetic variants known to be associated with atrial fibrillation in veteran endurance athletes.

    Cross sectional study. Measured at time for inclusion.

  • Changes in biochemical markers associated with atrial fibrosis and inflammation in veteran endurance athletes.

    Cross sectional study. Measured at time for inclusion.

  • +1 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

Age58 Years - 83 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Already included in the Birkebeiner studies or "Health and environment study in Oslo" (HELMILO)
  • Born 1960 and earlier

You may not qualify if:

  • Born before 1935.
  • Earlier heart valve surgery.
  • MI (Mitral Insufficiency)≥ grade 3
  • Ejection Fraction (EF) \<35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for DNA analysis and inflammation markers, Electronic ECG, Holter monitoring, Echocardiography

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marit Aaronaes, MD,PhD

    Diakonhjemmet Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of outpatient clinic, Marit Aaronaes, MD, PhD

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 15, 2018

Study Start

January 21, 2019

Primary Completion

November 11, 2020

Study Completion

July 1, 2022

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

NO(1)