Effects of Detraining in Endurance Athletes With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— NEXAF  

Official title:

Effects of Detraining in Endurance Athletes With Atrial Fibrillation (NEXAF Detraining)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991337
• Other study ID #: NEXAF Detraining
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2022
• Source: Vestre Viken Hospital Trust
• Contact: Marius Myrstad, MD;PhD
• Phone: +47 92255945
• Email: marium[@]vestreviken.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Detraining 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.
• Control 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.

Locations

Country	Name	City	State
Norway	Vestre Viken Health Trust, Baerum Hospital	Bærums Verk

Sponsors (7)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	AZ Jan Palfijn Gent, Baker Heart and Diabetes Institute, Jessa Hospital, St. Olavs Hospital, Universitaire Ziekenhuizen KU Leuven, University Hospital, Antwerp

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation burden	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.	Measured during the last 4 weeks (week 13-16) of the 16-week intervention period
Secondary	Atrial fibrillation burden	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.	Measured during the first 4 weeks (week 1-4) of the 16-week intervention period
Secondary	Atrial fibrillation burden	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.	Measured during week 5-8 of the 16-week intervention period
Secondary	Atrial fibrillation burden	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.	Measured during week 9-12 of the 16-week intervention period
Secondary	Cumulative atrial fibrillation burden	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.	Measured during the entire 16-week intervention period
Secondary	Atrial fibrillation episode duration	Mean duration of atrial fibrillation episodes lasting =30sec	Measured during the 16-week intervention period
Secondary	Atrial fibrillation episodes	Number of atrial fibrillation episodes lasting =30sec, as measured by insertable cardiac monitor	Measured during the first 4 weeks (week 1-4) of the 16-week intervention period
Secondary	Atrial fibrillation episodes	Number of atrial fibrillation episodes lasting =30sec, as measured by insertable cardiac monitor	Measured during week 5-8 of the 16-week intervention period
Secondary	Atrial fibrillation episodes	Number of atrial fibrillation episodes lasting =30sec, as measured by insertable cardiac monitor	Measured during week 9-12 of the 16-week intervention period
Secondary	Atrial fibrillation episodes	Number of atrial fibrillation episodes lasting =30sec, as measured by insertable cardiac monitor	Measured during the last 4 weeks (week 13-16) of the 16-week intervention period
Secondary	Cumulative atrial fibrillation episodes	Number of atrial fibrillation episodes lasting =30sec, as measured by insertable cardiac monitor	Measured during the 16-week intervention period
Secondary	Days with atrial fibrillation	Days with at least one episode of atrial fibrillation lasting =30sec	Measured during the 16-week intervention period
Secondary	Days without atrial fibrillation	Days without atrial fibrillation episodes	Measured during the 16-week intervention period
Secondary	Relative change in atrial fibrillation burden	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	Measured during the 4-week baseline period prior to randomization and during the last 4 weeks of the 16-week intervention period
Secondary	Relative change in atrial fibrillation burden	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	Measured during the 4-week baseline period prior to randomization and during the first 4 weeks of the 16-week intervention period
Secondary	Relative change in atrial fibrillation burden	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	Measured during the 4-week baseline period prior to randomization and during the entire 16-week intervention period
Secondary	Adherence to prescribed exercise	Adherence to prescribed exercise (>80% of exercise with =85% and =75% of maximum heart rate, respectively)	16 weeks
Secondary	Exercise capacity	Peak oxygen uptake (VO2peak)	Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Atrial volumes	Right and left atrial volumes measured with echocardiography	Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Ventricular volumes	Right and left ventricular volumes measured with echocardiography	Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Atrial function	Left atrial function measured by strain with echocardiography	Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Ventricular function	Right and left ventricular function measured by strain with echocardiography	Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Systolic function	Left ventricular ejection fraction measured by strain with echocardiography	Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Atrial fibrillation symptoms	Self-reported number of symptomatic atrial fibrillation episodes	Measured by questtionnaire at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Atrial Fibrillation Effect on QualiTy-of-life questionnaire	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	Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Atrial fibrillation hospitalizations	Number of unplanned hospitalizations due to atrial fibrillation cardioversion or ablation	Throughout study completion, an average of 22 weeks
Secondary	Modified European Heart Rhythm Association Symptom Scale (mEHRA) symptom classification	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	Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Secondary	Number of ventricular arrhythmias	Ventricular arrhythmias lasting =12 ventricular complexes as measured by continuous monitoring with insertable cardiac monitor	Throughout study completion, an average of 22 weeks
Secondary	Number of adverse events	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	Throughout study completion, an average of 22 weeks
Secondary	Cardiovascular risk factors measured by blood pressure	Measure of blood pressure (mmHg)	Measured at baseline and after the 16-week intervention period
Secondary	Cardiovascular risk factors measured by blood lipids	Blood lipids (mmol/L)	Measured at baseline and after the 16-week intervention period
Secondary	Cardiovascular risk factors measured by weight	Weight (kg)	Measured at baseline and after the 16-week intervention period
Secondary	Cardiovascular risk factors measured by BMI	BMI (weight and height will be combined to report BMI in kg/m^2)	Measured at baseline and after the 16-week intervention period
Secondary	Cardiovascular risk factors measured by smoking	Smoking (pack years)	Measured at baseline and after the 16-week intervention period
Secondary	Cardiovascular risk factors measured by alcohol units	Alcohol use (units)	Measured at baseline and after the 16-week intervention period
Secondary	Cardiovascular biomarkers - inflammation markers	Markers for inflammation markers; interleukines and hrCRP (mg/L)	Measured at baseline and after the 16-week intervention period
Secondary	Cardiovascular biomarkers - markers for myocardial damage	Markers for myocardial damage, measured by troponin T (ng/L) and NT-ProBNP (ng/L)	Measured at baseline and after the 16-week intervention period
Secondary	Immediate effects on arrhythmia burden of high-intensity exercise	Ahrrythmias measured with 24-hour electrocardiogram after peak exercise testing	24 hours after after peak exercise testing
Secondary	Immediate effects on biomarkers of exercise	Blood sampling at peak exercise for analyses of cardiac Troponins, NT-pro-BNP, interleukins, C-reactive protein	At peak exercise during cardiopulmonary exercise testing