Atrial Fibrillation Lifestyle Project

Last updated: October 26, 2018
Sponsor: Teddi Orenstein Lyall
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT03724383
H18-01441
F18-02253
  • Ages 19-75
  • All Genders

Study Summary

The objectives of the investigators are to demonstrate a reduction in frequency and symptoms of AF and improvements in cardiovascular risk factors following a lifestyle intervention in patients with paroxysmal AF. Participants will be randomized into control or intervention groups. The intervention will receive step trackers, diet counselling, an exercise program, and risk factor modification consultations. Controls will receive step trackers and care as usual. Testing will occur at baseline, six months, and one year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. paroxysmal, non-permanent, non-valvular AF. Patients with high burden of AF will beadmitted into the study ahead of low burden patients.

  2. Low burden paroxysmal AF is defined as: ≥4 episodes of AF over the past 24months; episodes terminate spontaneously within 7 days or via cardioversionwithin 48 hours of onset.

  3. High burden paroxysmal AF is defined as: ≥ 4 episodes of AF over the past 6months, with ≥ 2 episodes > 6 hours in duration; episodes terminate spontaneouslywithin 7 days or via cardioversion within 48 hours of onset.

  4. Early persistent AF is defined as: ≥ 2 episodes of AF over the past 24 months;episodes are successfully terminated via cardioversion within 7 days of onset.

  5. BMI equal to or greater than 27 kg/m^2, or central obesity using abdominalcircumference with ethnic specific values recommended by Canadian diabetesassociation.

  6. one of hypertension or diabetes

Exclusion

Exclusion Criteria:

  1. Permanent AF

  2. Estimated survival < 2 years

  3. Left ventricular ejection fraction < 40%

  4. Weight > 300 lbs, treadmill cannot hold greater weights

  5. Inability to walk one city block

  6. Severe musculoskeletal or neurological problems making them unable to exercise safely

  7. New York Heart Association class 3-4 heart failure

  8. Severe aortic valve stenosis

  9. Prior mitral valve surgery or severe stenosis or regurgitation

  10. Hypertrophic cardiomyopathy

  11. Patients with illnesses or medications that already cause atrial fibrillation on theirown, such as pericarditis, high doses of prednisone, and hyperthyroidism

  12. Any other absolute and relative contraindications to exercise testing

  13. Inability to speak and understand English

  14. In atrial fibrillation at time of baseline testing

  15. Defibrillator present

Study Design

Total Participants: 80
Study Start date:
September 06, 2018
Estimated Completion Date:
April 30, 2020

Study Description

Sixty percent of cases of non-valvular AF are associated with other modifiable risk factors, including: obesity, diabetes, hypertension, or sleep apnea. Treating modifiable risk factors has been shown to improve morbidity and mortality in patients with AF. Treatment of AF with antiarrhythmic drugs or catheter ablation has not been shown to improve survival. Recently, small cohort studies combining exercise, diet, and antiarrhythmic medications and/or ablation have shown improvements in cardiovascular risk factors and reduction in AF symptoms and frequency.

The aim of this study is to demonstrate a reduction in frequency and symptoms of AF and improvements in cardiovascular risk factors following a lifestyle intervention in patients with paroxysmal AF. This study uses a reproducible intensive supervised cardiac rehabilitation that includes exercise, diet, and risk factor modification for patients with paroxysmal, non-valvular AF. The investigators expect that a lifestyle intervention will show significant improvement in fitness and weight loss and improvements in AF symptoms and frequency, and cardiovascular risk factors when compared to a control group with paroxysmal AF and similar baseline characteristics who do not receive a diet and exercise program.

Connect with a study center

  • Garratt Wellness Centre

    Richmond, British Columbia V7C 3S9
    Canada

    Site Not Available

  • Richmond Cardiology Clinic

    Richmond, British Columbia V7C 5L9
    Canada

    Active - Recruiting

  • Richmond Health Services

    Richmond, British Columbia V6Y 3T6
    Canada

    Site Not Available

  • Richmond Hospital Cardiac Rehabilitation

    Richmond, British Columbia V6X 1A2
    Canada

    Site Not Available

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Live Well Clinic

    Vancouver, British Columbia V6M 3W6
    Canada

    Site Not Available

  • St. Paul's Healthy Heart Program

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

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