Detraining on Atrial Fibrillation

NCT03642886 | Unknown

• 1 other identifier: InterventionalCR
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Ratio of atrial fibrillation (AF) episodes

  Determine the effectiveness of systematic detraining on AF episodes (the number of AF AliveCor transmissions over the total number of daily transmissions (ECGaf/ECGtotal))

  0-32 weeks

• Symptomatic palpitations

  The number of patient reported symptomatic palpitations that correspond with documented atrial fibrillation (some participants may be experiencing AF but may not actually be symptomatic)

  0-32 weeks

Secondary Outcomes (7)

• AF symptom severity

  Taken at 0, 8, and 32 weeks

• Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score

  Taken at 0, 8, and 32 weeks

• General quality of life

  Taken at 0, 8, and 32 weeks

• Hospitalizations/emergency room visits

  0-32 weeks

• DC cardioversions

  0-32 weeks

Study Arms (2)

Continued Strenuous Exercise

NO INTERVENTION

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

Prescribed Detraining

EXPERIMENTAL

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

Behavioral: Prescribed Detraining

Interventions

Prescribed Detraining BEHAVIORAL

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.

Prescribed Detraining

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• BMI \> 25 kg/m2
• Hypertension as per 2016 Canadian Hypertension Education Program Guidelines\[52\]
• Diabetes
• Structural heart disease
• Obstructive sleep apnea
• Metabolic abnormalities (hyperthyroidism, pheochromocytoma)
• Pericarditis
• 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).
• Pre-excitation, Brugada syndrome, Long QT syndrome, arrhythmogenic cardiomyopathy or catecholaminergic polymorphic ventricular tachycardia
• Use of performance-enhancing agents
• Implanted cardiac pacemaker or defibrillator
• A concurrent period of involuntary deconditioning

Sponsors & Collaborators

• Cardiology Research UBC: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James McKinney, MD

  University of British Columbia Department of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James McKinney, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In adjudication of arrhythmia events the adjudicators would not know if the participants have been randomized to the detraining or control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director at SportsCardiologyBC

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 22, 2018
• Study Start: November 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: April 30, 2020
• Last Updated: November 2, 2018

Record last verified: 2018-10

Locations

CA (1)