Effectiveness of a Novel Intervention (Super Rehab) in Overweight Patients With Atrial Fibrillation (SuRe AF), a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Symptom burden, as defined by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
研究概览
简要总结
This study proposes to evaluate the effectiveness of a novel lifestyle intervention (Super Rehab), in addition to standard care, for patients with symptomatic atrial fibrillation (AF) requiring rhythm control strategy who are overweight.
As the main driver behind the selection of a rhythm-control strategy for patients with AF, the primary outcome will be an improvement in AF-related symptoms with Super Rehab versus Usual Care only. Secondary outcomes will include the burden of AF, biochemical and cardiac functional and structural changes, and markers of quality-of-life and health resource use.
详细描述
In this randomised controlled trial (RCT) the investigators will study the efficacy of a novel lifestyle intervention (Super Rehab), in addition to usual care, for patients with symptomatic atrial fibrillation (AF) where are a rhythm-control strategy is being employed who are overweight. Increasing evidence has shown that AF can respond to robust lifestyle change and aggressive risk factor modification, and in some case can in fact regress.
In the majority of cases, the decision to target a rhythm-control strategy for AF is based on the symptom-burden reported by the patient. This in light of the low volume of evidence suggesting any benefits of rhythm-control strategies over rate-control strategies based on prognostic clinical outcomes.
The modifiable cardiovascular (CV) risk factors that increase both CV risk and the frequency of its various forms of disease also impact the development and progression of AF. In addition, patients with multiple CV risk factors are at enhanced risk of both poorer long-term outcomes and earlier failures of traditional rhythm-control strategies.
This RCT study will involve patients who have described symptomatic AF such that their treating team have elected for a rhythm-control strategy (i.e. a combination of anti-arrhythmic therapy ± a referral for a direct current (DC) cardioversion and/or an ablation) who are also overweight (body mass index [BMI] ≥27kg/m2). The BMI criterion acts as a marker of CV risk that may respond to a lifestyle intervention, which has proved sensitive in other studies.
Participants will be randomised to either Super Rehab and Usual Care or to continue Usual Care only. Super Rehab includes a combination of 1:1 supervised high-intensity exercise, dietary advice sessions and 3-monthly clinical reviews to optimise CV risk factor management. The whole programme lasts 12 months. Participants in both arms will undergo imaging, fitness, clinical tests (including blood tests), and complete questionnaires on four occasions during the study.
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
It is not possible to blind either the participant or care providers to their study arm, however the outcome analysis will be undertaken blinded to study arm
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
- •Aged >18
- •Symptomatic AF (paroxysmal or persistent <12-months) with a rhythm control management strategy selected including consideration of referral for a cardioversion or ablation forming part of their planned pathway
- •BMI ≥27m/kg2
排除标准
- •Prognostic coronary artery disease, defined as left main stem >50% stenosis and/or ≥ moderate disease in ≥3 major epicardial vessels requiring revascularisation.
- •Unstable angina
- •New York Heart Association class III/IV heart failure or severe left ventricular impairment
- •Significant cardiomyopathy (as assessed by Cardiologist, e.g. hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy)
- •Severe heart valve disease
- •Severe hypertension (BP >180/120mmHg) despite optimising anti-hypertensive therapy
- •Uncontrolled arrhythmia or higher degree heart block
- •History of aortic dissection
- •Recent acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack (<6 months)
- •Severe autonomic or peripheral neuropathy
- •Significant acute or chronic renal failure that would preclude contrast use at CT
- •Significant pulmonary fibrosis or interstitial lung disease (as assessed by a pulmonary physician)
- •Physically unable to participate in high-intensity exercise
- •Pregnancy
- •Prior AF ablation
- •A clinically significant ECG abnormality at the screening visit, which in the opinion of the investigators exposes the subject to risk by enrolling in the trial, including but not limited to: sustained ventricular tachycardia, high-grade atrioventricular block (second-degree Mobitz type II or third-degree heart block), evidence of acute ischemia (ST-segment elevation or depression >1 mm), or other arrhythmias deemed clinically significant by the study cardiologist.
- •Participation in another intervention-based research study
- •Inability to fully understand the instructions provided during the study
结局指标
主要结局
Symptom burden, as defined by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
时间窗: Month 12
As the primary outcome, an atrial fibrillation-specific measure of symptoms and quality of life will be assessed using the University of Toronto Atrial Fibrillation Severity Scale (AFSS) questionnaire. Scores range from 0 to 35, with higher scores indicating greater AF symptom severity. Differences between groups will be assessed at 12 months, with additional assessments conducted and reported at 6- and 15-month time points.
次要结局
- Anthropometrics - abdominal waist circumference(Month 12)
- Cardiac structural and functional assessment with echocardiography(Month 12)
- % burden of AF(Month 12)
- Duration and number of AF episodes(Month 12)
- Time to first arrhythmia recurrence(Month 12)
- Anthropometrics - Body weight(12 months)
- Anthropometrics - body mass index(Month 12)
- Anthropometrics - abdominal waist circumference(Month 12)
- Cardiorespiratory fitness(Month 12)
- Visceral fat(Month 12)
- Cardiac structural and functional assessment with echocardiography(Month 12)
- CTCA based changes in left atrial structure(Month 12)
- Blood pressure control(Month 12)
- Serum lipid levels(Month 12)
- Glucose control (HbA1c)(Month 12)
- Inflammatory marker (high-sensitivity C-reactive protein)(Month 12)
- Physical activity(12 months)
- European Heart Rhythm Association (EHRA) AF-score(Month 12)
- Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire(Month 12)
- EuroQol Group (EuroQol) EQ-5D-5L questionnaire(Month 12)
- Hospital Anxiety and Depression Scale (HADS)(Month 12)
- ICEpop CAPability measure for Adults (ICECAP-A)(Month 12)
- Resource-use questionnaire(Month 12)