Recruiting

Observational Study

Sponsor:

Cardiology Research UBC

Code:

NCT03642886

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Prescribed Detraining

Study Details

Brief summary:

This study will examine the effect of detraining as a clinical tool to prevent recurrence of lone paroxysmal atrial fibrillation (AF) and improve quality of life. Persons who engage in endurance activity with AF will be randomly assigned to undergo an 8-week period of detraining or encouraged to maintain their current level of exercise. Participants will receive a handheld device called AliveCor that can record an electrical tracing of the heart rhythm by pressing down with ones' thumbs. The amount of arrhythmia and symptoms will be recorded. The research team hypothesizes that among athletes with lone AF, an 8-week period of detraining will not affect atrial fibrillation recurrence or quality of life.

Conditions

Atrial Fibrillation

Study ID

NCT03642886

Start date

Nov 1, 2018

Status verified date

Oct, 2018

Completion date

Apr 30, 2020

Anticipated

Primary completion date

Jun 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age between 18 and 60
2. Paroxysmal AF (eligible subjects must have had >1episode of AF within the last 12 months)
3. Performs prolonged regular sessions of strenuous practice (≥6h/week with intensity greater than 60% of maximum heart rate for at least 6 months prior)
4. Preserved ejection fraction (≥ 55%) with an absence of structural heart disease (hypertrophic cardiomyopathy, valvular heart disease, hypertensive heart disease)

Exclusion Criteria:

1. BMI > 25 kg/m2
2. Hypertension as per 2016 Canadian Hypertension Education Program Guidelines\[52\]
3. Diabetes
4. Structural heart disease
5. Obstructive sleep apnea
6. Metabolic abnormalities (hyperthyroidism, pheochromocytoma)
7. Pericarditis
8. Coronary artery disease (defined as history of myocardial infarction, angina, q-waves on resting ECG, perfusion defect on nuclear scan, wall-motion abnormality on echocardiogram).
9. Pre-excitation, Brugada syndrome, Long QT syndrome, arrhythmogenic cardiomyopathy or catecholaminergic polymorphic ventricular tachycardia
10. Use of performance-enhancing agents
11. Implanted cardiac pacemaker or defibrillator
12. A concurrent period of involuntary deconditioning

Study Design

Enrollment

73 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Continued Strenuous Exercise

Continued strenuous athletics (no reduction in training volume) - athletes will be asked to document their activity and be fitted with an activity monitor during the run-in period and intervention period

experimental: Prescribed Detraining

Detraining period of 8-weeks which is defined as:

1. a 75% decrease in the amount of exercise (from baseline)
2. a 50% decrease in the intensity of exercise as measured in METS (from baseline)
3. Mitchell Classification classes 1A, 2A, 2B of activity are permitted

Interventions

Prescribed Detraining

Detraining is the deliberate act of reducing volume of exercise to observe subsequent changes in cardiac indices over time or the partial or complete loss of training of induced anatomical, physiological and performance adaptions. Detraining is primarily employed as a diagnostic tool to help differentiate Athletes' heart from cardiac pathology.

Primary outcome measure

  • Ratio of atrial fibrillation (AF) episodes [ Time Frame: 0-32 weeks ]
  • Symptomatic palpitations [ Time Frame: 0-32 weeks ]

Central Contacts and Locations

Central contacts

James McKinney, MD

604-822-1747mckinney.jimmy@gmail.com

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

More Information

Sponsor

Cardiology Research UBC

Last update posted

Nov 2, 2018

Last verified

Oct, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiology Research UBC on 2018-11-02.