Atrial Fibrillation
Conditions
Keywords
heart
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.
Interventions
BEHAVIORALDetraining group
Detraining is defined as exercise corresponding to a heart rate ≤75% of maximum heart rate and ≤80% of the self-reported average weekly amount of exercise (hours/week) during the past six months, for a period of 16 weeks.
BEHAVIORALControl group
At least three weekly sessions of high intensity exercise, corresponding to a heart rate ≥85% of maximum heart rate, and otherwise continue endurance exercise as usual.
Sponsors
St. Olavs Hospital
Baker Heart and Diabetes Institute
Universitaire Ziekenhuizen KU Leuven
University Hospital, Antwerp
AZ Jan Palfijn Gent
Jessa Hospital
Vestre Viken Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Open label study and participants are not blinded to group allocation. Researchers and staff are unblinded during all procedures. AF burden will be adjudicated by a blinded endpoint committee and researchers will be blinded to group allocation when performing statistical analyses.
Intervention model description
Two-arm international multicenter open-label randomized (1:1) controlled trial with blinded end-point evaluation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation burden | Measured during the last 4 weeks (week 13-16) of the 16-week intervention period | Atrial fibrillation burden (time with atrial fibrillation) as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring and reported as percentages. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative atrial fibrillation burden | Measured during the entire 16-week intervention period | Atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring. |
| Atrial fibrillation episode duration | Measured during the 16-week intervention period | Mean duration of atrial fibrillation episodes lasting ≥30sec |
| Atrial fibrillation episodes | Measured during the first 4 weeks (week 1-4) of the 16-week intervention period | Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor |
| Cumulative atrial fibrillation episodes | Measured during the 16-week intervention period | Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor |
| Days with atrial fibrillation | Measured during the 16-week intervention period | Days with at least one episode of atrial fibrillation lasting ≥30sec |
| Days without atrial fibrillation | Measured during the 16-week intervention period | Days without atrial fibrillation episodes |
| Relative change in atrial fibrillation burden | Measured during the 4-week baseline period prior to randomization and during the last 4 weeks of the 16-week intervention period | Relative change in atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring |
| Adherence to prescribed exercise | 16 weeks | Adherence to prescribed exercise (\>80% of exercise with ≥85% and ≤75% of maximum heart rate, respectively) |
| Exercise capacity | Measured at the baseline study visit and at the final study visit after the 16-week intervention period | Peak oxygen uptake (VO2peak) |
| Atrial volumes | Measured at the baseline study visit and at the final study visit after the 16-week intervention period | Right and left atrial volumes measured with echocardiography |
| Ventricular volumes | Measured at the baseline study visit and at the final study visit after the 16-week intervention period | Right and left ventricular volumes measured with echocardiography |
| Atrial function | Measured at the baseline study visit and at the final study visit after the 16-week intervention period | Left atrial function measured by strain with echocardiography |
| Ventricular function | Measured at the baseline study visit and at the final study visit after the 16-week intervention period | Right and left ventricular function measured by strain with echocardiography |
| Systolic function | Measured at the baseline study visit and at the final study visit after the 16-week intervention period | Left ventricular ejection fraction measured by strain with echocardiography |
| Atrial fibrillation symptoms | Measured by questtionnaire at the baseline study visit and at the final study visit after the 16-week intervention period | Self-reported number of symptomatic atrial fibrillation episodes |
| Atrial fibrillation burden | Measured during the first 4 weeks (week 1-4) of the 16-week intervention period | Atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring. |
| Atrial fibrillation hospitalizations | Throughout study completion, an average of 22 weeks | Number of unplanned hospitalizations due to atrial fibrillation cardioversion or ablation |
| Modified European Heart Rhythm Association Symptom Scale (mEHRA) symptom classification | Measured at the baseline study visit and at the final study visit after the 16-week intervention period | Modified European Heart Rhythm Association Symptom Scale (mEHRA) questionnaire. The scale ranges from minimum 1 to maxiumum 4, a higher score indicates a worse symptom burden |
| Number of ventricular arrhythmias | Throughout study completion, an average of 22 weeks | Ventricular arrhythmias lasting ≥12 ventricular complexes as measured by continuous monitoring with insertable cardiac monitor |
| Number of adverse events | Throughout study completion, an average of 22 weeks | Any unfavorable and unintended sign, symptom or illness that develops or worsens during the trial period will be reported as adverse events (AE). A serious adverse event (SAE) is defined as death, any life-threatening event or any inpatient hospitalisation |
| Cardiovascular risk factors measured by blood pressure | Measured at baseline and after the 16-week intervention period | Measure of blood pressure (mmHg) |
| Cardiovascular risk factors measured by blood lipids | Measured at baseline and after the 16-week intervention period | Blood lipids (mmol/L) |
| Cardiovascular risk factors measured by weight | Measured at baseline and after the 16-week intervention period | Weight (kg) |
| Cardiovascular risk factors measured by BMI | Measured at baseline and after the 16-week intervention period | BMI (weight and height will be combined to report BMI in kg/m\^2) |
| Cardiovascular risk factors measured by smoking | Measured at baseline and after the 16-week intervention period | Smoking (pack years) |
| Cardiovascular risk factors measured by alcohol units | Measured at baseline and after the 16-week intervention period | Alcohol use (units) |
| Cardiovascular biomarkers - inflammation markers | Measured at baseline and after the 16-week intervention period | Markers for inflammation markers; interleukines and hrCRP (mg/L) |
| Cardiovascular biomarkers - markers for myocardial damage | Measured at baseline and after the 16-week intervention period | Markers for myocardial damage, measured by troponin T (ng/L) and NT-ProBNP (ng/L) |
| Immediate effects on arrhythmia burden of high-intensity exercise | 24 hours after after peak exercise testing | Ahrrythmias measured with 24-hour electrocardiogram after peak exercise testing |
| Immediate effects on biomarkers of exercise | At peak exercise during cardiopulmonary exercise testing | Blood sampling at peak exercise for analyses of cardiac Troponins, NT-pro-BNP, interleukins, C-reactive protein |
| Atrial Fibrillation Effect on QualiTy-of-life questionnaire | Measured at the baseline study visit and at the final study visit after the 16-week intervention period | Measured with the Atrial Fibrillation Effect on QualiTy-of-life questionnaire (AFEQT). Minimum score 0, maximum score 100, higher values indicate better quality of life |
Countries
Norway
Contacts
Primary ContactMarius Myrstad, MD;PhD
Backup ContactMarius Myrstad, MD, PhD
Outcome results
None listed