Clinical trial NCT04991337: Effects of Detraining in Endurance Athletes With Atrial Fibrillation
Official title: Effects of Detraining in Endurance Athletes With Atrial Fibrillation (NEXAF Detraining)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: heart
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Baker Heart and Diabetes Institute
name: Universitaire Ziekenhuizen KU Leuven
name: University Hospital, Antwerp
name: AZ Jan Palfijn Gent
name: Jessa Hospital
First posted: 2021-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm international multicenter open-label randomized (1:1) controlled trial with blinded end-point evaluation.
Primary purpose: TREATMENT

Brief summary: Atrial fibrillation (AF) affects more than 43 million people worldwide, but specific exercise recommendations do not exist for this group of patients. Despite a lack of evidence, athletes are often advised to reduce exercise intensity (detraining) after being diagnosed with AF. This randomized controlled trial will be the first study that investigates effects of detraining in endurance athletes. Participants will be randomized to an intervention group that will be instructed to refrain from high intensity exercise, and a control group. The study aims to clarify whether detraining might reduce the burden of AF and has the potential to guide development of exercise guidelines for AF patients.

Detailed description: Atrial fibrillation (AF) affects more than 43 million people worldwide, but specific exercise recommendations do not exist for this group of patients. Despite a lack of evidence, athletes are often advised to reduce exercise intensity (detraining) after being diagnosed with AF. This randomized controlled trial will be the first study that investigates effects of detraining in endurance athletes. Participants will be included at Bærum Hospital, St.Olavs Hospital, Trondheim, Baker Institute, Melbourne, Leuven University Hospital, Antwerp University Hospital, AZ Jan Palfijn Gent and Jessa Hospital Hasselt, Belgium. In total 120 participants will be monitored with a chest-strap heart rate (HR) monitor and sportswatch (exercise intensity), and an Insertable Cardiac Monitor (ICM, AF burden). Participants will be randomized to an intervention group (n=60) that will be instructed to refrain from high intensity exercise (H) \>75% of maximal HR (HRmax)) for a period of 16 Weeks, or a control group (n=60) that will be instructed to perform at least three weekly sessions of high intensity training (HR ≥85% of HRmax. The primary endpoint will be AF burden, as measured by continuous monitoring with ICMs and calculated as the cumulative duration of all AF episodes lasting ≥30sec divided by total duration of monitoring. The study aims to clarify whether detraining might reduce the burden of AF and has the potential to guide development of exercise guidelines for AF patients. The investigators will also study exercise-induced cardiac remodeling, aiming to improve the understanding of underlying pathophysiological mechanisms for AF.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years
* Diagnosed with paroxysmal atrial fibrillation (verified by electrocardiogram)
* Report \>5 (running, rowing) or \>8 (cycling, cross-country skiing), weekly hours, respectively, of endurance sport
* At least two anamnestic (self-reported) episodes of atrial fibrillation, of which one during the last six months
* Use a smartphone and agree to connect their sportswatch with a web-based platform for monitoring of exercise

Exclusion Criteria:

* Permanent atrial fibrillation
* Cardiac conditions (including valvular heart disease of moderate or greater severity, symptomatic ischemic heart disease)
* Left ventricular ejection fraction \<45%
* Hypertension (\>140/90)
* Diabetes mellitus
* Hyperthyroidism
* Smoking during the last 5 years
* Alcohol intake \>20 alcohol units/week
* Use of illegal or performance enhancing drugs
* Body mass index \>30kg/m2
* Injuries preventing physical exercise
* Pregnancy
* Participation in conflicting intervention research studies
* Planned atrial fibrillation ablation within the next six months
* The individual refuses to have an insertable cardiac monitor, blood samples taken or be part of the detraining group

Primary outcomes:
measure: Atrial fibrillation burden
timeFrame: Measured during the last 4 weeks (week 13-16) of the 16-week intervention period
Secondary outcomes:
measure: Atrial fibrillation burden
timeFrame: Measured during the first 4 weeks (week 1-4) of the 16-week intervention period
measure: Atrial fibrillation burden
timeFrame: Measured during week 5-8 of the 16-week intervention period
measure: Atrial fibrillation burden
timeFrame: Measured during week 9-12 of the 16-week intervention period
measure: Cumulative atrial fibrillation burden
timeFrame: Measured during the entire 16-week intervention period
measure: Atrial fibrillation episode duration
timeFrame: Measured during the 16-week intervention period
measure: Atrial fibrillation episodes
timeFrame: Measured during the first 4 weeks (week 1-4) of the 16-week intervention period
measure: Atrial fibrillation episodes
timeFrame: Measured during week 5-8 of the 16-week intervention period
measure: Atrial fibrillation episodes
timeFrame: Measured during week 9-12 of the 16-week intervention period
measure: Atrial fibrillation episodes
timeFrame: Measured during the last 4 weeks (week 13-16) of the 16-week intervention period
measure: Cumulative atrial fibrillation episodes
timeFrame: Measured during the 16-week intervention period
measure: Days with atrial fibrillation
timeFrame: Measured during the 16-week intervention period
measure: Days without atrial fibrillation
timeFrame: Measured during the 16-week intervention period
measure: Relative change in atrial fibrillation burden
timeFrame: Measured during the 4-week baseline period prior to randomization and during the last 4 weeks of the 16-week intervention period
measure: Relative change in atrial fibrillation burden
timeFrame: Measured during the 4-week baseline period prior to randomization and during the first 4 weeks of the 16-week intervention period
measure: Relative change in atrial fibrillation burden
timeFrame: Measured during the 4-week baseline period prior to randomization and during the entire 16-week intervention period
measure: Adherence to prescribed exercise
timeFrame: 16 weeks
measure: Exercise capacity
timeFrame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Atrial volumes
timeFrame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Ventricular volumes
timeFrame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Atrial function
timeFrame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Ventricular function
timeFrame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Systolic function
timeFrame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Atrial fibrillation symptoms
timeFrame: Measured by questtionnaire at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Atrial Fibrillation Effect on QualiTy-of-life questionnaire
timeFrame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Atrial fibrillation hospitalizations
timeFrame: Throughout study completion, an average of 22 weeks
measure: Modified European Heart Rhythm Association Symptom Scale (mEHRA) symptom classification
timeFrame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
measure: Number of ventricular arrhythmias
timeFrame: Throughout study completion, an average of 22 weeks
measure: Number of adverse events
timeFrame: Throughout study completion, an average of 22 weeks
measure: Cardiovascular risk factors measured by blood pressure
timeFrame: Measured at baseline and after the 16-week intervention period
measure: Cardiovascular risk factors measured by blood lipids
timeFrame: Measured at baseline and after the 16-week intervention period
measure: Cardiovascular risk factors measured by weight
timeFrame: Measured at baseline and after the 16-week intervention period
measure: Cardiovascular risk factors measured by BMI
timeFrame: Measured at baseline and after the 16-week intervention period
measure: Cardiovascular risk factors measured by smoking
timeFrame: Measured at baseline and after the 16-week intervention period
measure: Cardiovascular risk factors measured by alcohol units
timeFrame: Measured at baseline and after the 16-week intervention period
measure: Cardiovascular biomarkers - inflammation markers
timeFrame: Measured at baseline and after the 16-week intervention period
measure: Cardiovascular biomarkers - markers for myocardial damage
timeFrame: Measured at baseline and after the 16-week intervention period
measure: Immediate effects on arrhythmia burden of high-intensity exercise
timeFrame: 24 hours after after peak exercise testing
measure: Immediate effects on biomarkers of exercise
timeFrame: At peak exercise during cardiopulmonary exercise testing
Other outcomes:
Locations:
city: Bærums Verk
country: Norway
facility: Vestre Viken Health Trust, Baerum Hospital
Study officials:
affiliation: Vestre Viken Health trust
name: Marius Myrstad, |MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: