Lifestyle Modification for the Treatment of Symptomatic Atrial Fibrillation - A Pilot Study - The LIFE-AF Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Changes in AFIB-related symptom burden
Study Overview
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 number of atrial fibrillation episodes as well as gain an understanding of the impact of these changes on the gut microbiome.
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 sinus rhythm) by implementing current evidence-based lifestyle recommendations as well as gain an understanding of the impact of these changes in the gut microbiome.
Objectives:
This study aims to determine if a multicomponent risk factor modification intervention (dietary intervention, exercise regimen and behavioural therapy) implemented using a basic healthcare team reduces the burden of AFIB at 12 months by decreasing the length and number of AFIB episodes. This study aims to assess the impact of these interventions on AFIB-related symptoms, quality of life and rhythm status (documented on an implantable loop recorder [ILR]).This study aims to examine the gut microbiota and identify potential organisms which may be present in higher concentrations in patients with an elevated BMI and AFIB and how these organism levels may alter with dietary changes.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Data downloaded from the participants' implantable loop recorders will not be available to the investigators nor anyone involved in direct patient interaction in the study. A blinded event committee composed of three physicians with a specialization in cardiology, who are not directly involved in the research study, will have access to this data.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Experimental Arm
Multicomponent Risk Factor Modification Intervention focused on healthy eating, regular exercise and behavioural therapy
Intervention: Multicomponent Risk Factor Modification (Behavioral)
Control Arm
Standard Clinical Practice
Outcomes
Primary Outcomes
Changes in AFIB-related symptom burden
Time Frame: baseline to 1, 3, 6 and 12 months
To assess the impact of a lifestyle intervention on AFIB-related symptom burden as measured by the University of Toronto AFIB Severity Scale (AFSS) scores at 1, 3, 6, and 12 months. This is a validated scale (range, 3.25 \[single minimally symptomatic episode lasting minutes\] to 30 \[continuous highly symptomatic episode lasting \>48hours\]) which encompasses 3 domains of atrial fibrillation: event frequency (scored 1-10), duration (scored 1.25-10), and global episode severity (scored 1-10).
Changes in levels of monosaccharides in the gut microbiota
Time Frame: baseline to 12 months
Identification of the gastrointestinal microbiota composition at baseline and dysbiosis at 12 months as a result of dietary intervention. Microbial DNA will be extracted from fecal samples, 16S rRNA genes will be amplified, and analyses will be performed to determine levels of monosaccharides in the gut microbiota at baseline and at 12 months.
Combined incidence of stroke, myocardial infarction and hospitalization
Time Frame: 12 months
To assess the impact of a lifestyle intervention on a composite end-point at 12 months (combined stroke, myocardial infarction and hospitalization). This information will be collected from hospital records.
Changes in AFIB burden
Time Frame: baseline to 1, 3, 6, and 12 months
To assess the impact of a lifestyle intervention on AFIB burden as documented from implantable loop recorders at 1, 3, 6 and 12 months. We will document the change in the number of AFIB episodes. This will be monitored by the ILR recording device where any episode of AFIB over 30 seconds will count as 1 episode. The AFIB events recorded by the device will be adjudicated for accuracy using 2 raters.
Changes in Quality of Life based on Treatment Concerns and Daily Activity
Time Frame: baseline to 1, 3, 6, and 12 months
To assess the impact of a lifestyle intervention (multicomponent risk factor modification) on quality of life at 1, 3, 6, and 12-months using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire. This assesses treatment concerns and daily activity.
Changes in levels of short-chain fatty acids in the gut microbiota
Time Frame: baseline to 12 months
Identification of the gastrointestinal microbiota composition at baseline and dysbiosis at 12 months as a result of dietary intervention. Microbial DNA will be extracted from fecal samples, 16S rRNA genes will be amplified, and analyses will be performed to determine levels of short-chain fatty acids in the gut microbiota at baseline and at 12 months.
Secondary Outcomes
- Adherence to the lifestyle intervention diet recommendations(1, 3, 6 and 12 months)
- Adherence to the lifestyle intervention physical activity recommendations using MESA TWPAS(1, 3, 6 and 12 months)
- Changes in Physical Activity Levels Based on Step-Counts(1, 3, 6, and 12 months)
- Changes in Physical Activity Levels Based on Duration (minutes) of Physical Activity(1, 3, 6, and 12 months)
- Change in weight(baseline to 1, 3, 6 and 12 months)
- Adherence to the lifestyle intervention physical activity recommendations using IPAQ(1, 3, 6 and 12 months)
Investigators
Dr. Benedict Glover
Principal Investigator, Chief of Cardiac Arrhythmia Service, Department of Medicine
Queen's University