Status:
UNKNOWN
Lifestyle Modification for the Treatment of Symptomatic Atrial Fibrillation (LIFE-AF)
Lead Sponsor:
Dr. Benedict Glover
Collaborating Sponsors:
Abbott
University of Toronto
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effectiveness of a lifestyle modification intervention focused on healthy eating, regular exercise and behavioural therapy to decrease the length and numbe...
Detailed Description
Proposed research: This pilot study will evaluate the potential efficacy and feasibility of risk factor modification in patients with a known history of symptomatic paroxysmal and persistent AFIB (in...
Eligibility Criteria
Inclusion
- paroxysmal or persistent AFIB (in sinus rhythm at the time of randomization)
- BMI \> 30 kg/m\^2 or a waist circumference greater than 100 cm (male) or 90 cm (female)
- have daily access to an iPhone
- have at least one of the following risk factors:hypertension, diabetes or pre-diabetes, hyperlipidemia, smoker, obstructive sleep apnea
Exclusion
- Permanent AFIB (AFIB lasting \> 1 year)
- Prior or actively on waiting list for catheter ablation for AFIB
- History of unstable angina not corrected with revascularization
- Left ventricular ejection fraction \<30%
- Left atrial size \>5.5 cm
- New York Heart Association (NYHA) classification IV heart failure
- Moderate or severe cardiac valvular lesion (stenosis or regurgitation) on echocardiography or valvular lesion requiring intervention.
- Participation in a cardiac rehabilitation program within the last year
- Serious underlying psychiatric disorder: e.g. eating disorder, severe psychotic disorder with recent (3 month) hospitalization or psychiatric illness requiring supervised care precluding full independent function.
- Participants who are unable or unwilling to provide fully informed consent.
- Currently performing exercise training 150 minutes/week of moderate to vigorous physical activity
- Gastrointestinal malabsorption disorder: A previously diagnosed gastrointestinal malabsorption disorder interfering with macro or micronutrient absorption.
- If receiving warfarin and unstable international normalized ratio (INR) defined as persistently outside of the therapeutic range (2.0-3.0) for greater than 14 consecutive days.
- Other non-cardiovascular medical conditions making 1-year survival unlikely.
Key Trial Info
Start Date :
October 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03785418
Start Date
October 29 2018
End Date
July 1 2020
Last Update
December 26 2018
Active Locations (1)
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1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L2V7