Clinical trial NCT03724383: Atrial Fibrillation Lifestyle Project
Official title: Atrial Fibrillation Lifestyle Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Keywords: Non-permanent atrial fibrillation
Non-valvular atrial fibrillation
Nutrition
Diet
Exercise
Physical Activity
Sleep Apnea
Cardiovascular Risk
Obesity
Hypertension
Diabetes
Risk Factor Management
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health
name: Vancouver Coastal Health Research Institute
name: University of British Columbia
First posted: 2018-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel-group randomized controlled trial. Consecutive patients meeting eligibility criteria that are seen for routine cardiology follow-up will be invited to participate in this study. Patients who accept the possibility of diet counseling and exercise program will be randomized and stratified to 'control arm' versus 'intervention arm.' The final study results will be reported after completion of one-year follow up. We will also carry out a mid-study data analysis at six-months. Forty patients will be randomized to control arm and 40 patients randomized to the intervention arm. Intervention will include Phase 1, a six month program including three months of diet counseling combined with home exercise, followed by three months (starting at week 13) of an in-hospital, Cardiac rehabilitation exercise program. Phase 2 of the intervention will include six months of home-based maintenance exercise and diet (starting at week 25). The entire intervention period will be one year.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

   1. Low burden paroxysmal AF is defined as: ≥4 episodes of AF over the past 24 months; episodes terminate spontaneously within 7 days or via cardioversion within 48 hours of onset.
   2. High burden paroxysmal AF is defined as: ≥ 4 episodes of AF over the past 6 months, with ≥ 2 episodes \> 6 hours in duration; episodes terminate spontaneously within 7 days or via cardioversion within 48 hours of onset.
   3. 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.
2. BMI equal to or greater than 27 kg/m\^2, or central obesity using abdominal circumference with ethnic specific values recommended by Canadian diabetes association.
3. one of hypertension or diabetes

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 their own, 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

Primary outcomes:
measure: Changes in frequency of atrial fibrillation
timeFrame: Baseline to 6 months and 1 year
measure: Changes in severity of atrial fibrillation
timeFrame: Baseline to 6 months and 1 year
measure: Changes in Quality of Life on SF36
timeFrame: Baseline to 6 months and 1 year
Secondary outcomes:
measure: Changes in number of medications
timeFrame: Baseline and 1 year
measure: Systolic and Diastolic Blood Pressure
timeFrame: Baseline, 6 months, 1 year
measure: Hemoglobin A1C
timeFrame: Baseline, 6 months, 1 year
measure: Body Mass Index
timeFrame: Baseline, 6 months, 1 year
measure: Waist Circumference
timeFrame: Baseline, 6 months, 1 year
measure: Relative Fat Mass
timeFrame: Baseline, 6 months, 1 year
measure: Low density lipoprotein
timeFrame: Baseline, 6 months, 1 year
measure: Apnea hypopnea index
timeFrame: Baseline, 6 months, 1 year
measure: Metabolic equivalents (METs)
timeFrame: Baseline, 6 months, 1 year
measure: Left Atrial Volume Index
timeFrame: Baseline,1 year
measure: Diastolic Function Grade
timeFrame: Baseline, 1 year
measure: Left Atrial Pressure
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Richmond Hospital Cardiac Rehabilitation
state: British Columbia
city: Richmond
country: Canada
facility: Richmond Health Services
state: British Columbia
city: Richmond
country: Canada
facility: Garratt Wellness Centre
state: British Columbia
city: Richmond
country: Canada
facility: Richmond Cardiology Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Live Well Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Healthy Heart Program
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Teddi Orenstein Lyall, MD
role: PRINCIPAL_INVESTIGATOR
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