Lifestyle Modification for the Treatment of Symptomatic Atrial Fibrillation - A Pilot Study - The LIFE-AF Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in levels of monosaccharides in the gut microbiota
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Experimental Arm
Multicomponent Risk Factor Modification Intervention focused on healthy eating, regular exercise and behavioural therapy
干预措施: Multicomponent Risk Factor Modification (Behavioral)
Control Arm
Standard Clinical Practice
结局指标
主要结局
Changes in levels of monosaccharides in the gut microbiota
时间窗: 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.
Changes in AFIB-related symptom burden
时间窗: 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).
Combined incidence of stroke, myocardial infarction and hospitalization
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Dr. Benedict Glover
Principal Investigator, Chief of Cardiac Arrhythmia Service, Department of Medicine
Queen's University