Catheter Ablation vs. Antiarrhythmic Drugs and Risk Factor Modification. PRAGUE-25 Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Freeedom from atrial fibrillation and/or atrial tachycardia
研究概览
简要总结
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with a prevalence of 2% in general population. Incidence and prevalence of AF has been slightly increasing due to increasing age, improved ability to treat cardiac diseases, and higher incidence of obesity and other risk factors associated with AF. AF is associated with higher morbidity and mortality mainly caused by heart failure and stroke. Catheter ablation (with pulmonary vein isolation as a cornerstone) presents the most effective treatment method of AF. Recent observational studies have shown that intensive risk factor and lifestyle modifications, such as weight loss, reduced alcohol intake, and increased physical activity, are also associated with improved rhythm outocome. Head-to-head comparison of this very different methods has not been done yet. The aim of the project is to compare the effect of catheter ablation with lifestyle modification (risk factor modification) in a prospective, randomized, multicenter study on the maintenance of sinus rhythm (monitored using implantable ECG reveal), and on the progression of the fibrosis of the left ventricle.
详细描述
GOALS OF THE PROJECT The aim of our study is to compare the effect of the invasive strategy (catheter ablation) of atrial fibrillation with non-invasive strategy (non-amiodarone antiarrhythmic drugs with risk factor modification) in a prospective, multicenter, randomized, non-inferiority study. The main hypothesis is that strict risk factor modification (weight loss, physical exercise improvement, and alcohol reduction) with AADs in patients with AF will be associated with similar rhythm outcomes as catheter ablation. Beside the AF-recurrence as the primary endpoint, the secondary endpoints will be the AF burden (assessed using repeated Holter recordings), change in cardiorespiratory exercise (assessed using cardiopulmonary exercise test), MRI endpoints (diffuse myocardial fibrosis, epicardial adipose tissue), QoL (assessed using specific questionaiires), and metabolic endpoints (lipids, pro-inflammatory cytokines),
JUSTIFICATION OF THE PROJECT The main reason for the project is the large and ever-increasing number of AF patients, especially in light of the significant incidence of obesity in AF patients. Keeping in mind the high number of AF patients (≈ 2% of the population), its increasing incidence and prevalence, even if CAs were associated with a 100% success rate, it would be impossible to treat all AF patients using CA. A significant portion of patients with AF are obese. For instance, the median BMI was 29.2 in the EAST-AFNET Trial and 30 in the CABANA Trial. Furthermore, and this is the second reason for the project, a significant portion of AF patients are afraid of invasive procedures and would prefer a noninvasive approach if the efficacy of this approach is known. The third reason is to compare the effect of these two different methods on the structural and metabolic abnormalities associated with AF and obesity
METHODS The study is planned as prospective, multicenter, randomized, non-inferiority trial comparing two different approaches in the treatment of AF. Symptomatic AF patients indicated for rhythm control strategy (i.e. restoriation and maintenance of SR) will be enrolled and randomized to catheter ablation or risk factor modification.
Study population - inclusion criteria (all of three have to be met for enrollment) (i) symptomatic AF (paroxysmal, persistent, or long-standing persistent), and (ii) BMI ≥ 30, and (iii) signed informed content
Study population - exclusion criteria:
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
- None
盲法说明
prospective, randomized, open - label, non-inferiority study
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(all three must be met):
- •symptomatic atrial fibrillation
- •BMI ≥ 30, and
- •signed informed content
排除标准
- •permanent AF
- •severe valve disease (significant aortic stenosis, mitral regurgitation ≥ 3)
- •left ventricular ejection fraction < 40%
- •severe pulmonary hypertension (PAP > 40 mm Hg)
- •history of tachycardia-induced cardiomyopathy
- •manifest coronary artery disease
- •pregnancy
- •left atrial size ≥ 60 mm
- •indication for surgical treatment of obesity
- •diabetes mellitus on insulintreatment
- •age ≥ 75 let
- •a significant physical limitation that could affect physical activity (musculoskeletal disorders, COPD)
- •life expectancy less than 2 years
结局指标
主要结局
Freeedom from atrial fibrillation and/or atrial tachycardia
时间窗: 6 months after the procedure at least, and later during the follow-up
An absence of any paroxysm of atrial fibrillaton or atrial tachycardia lasting then 30 second, as assessed using repeated 7-day Holter recordings
次要结局
- Weight(12 months)
- MRI endpoint(baselien and 12months)
- Triglycerides(12 months)
- Hospitalization for AF(12 months)
- A composite of stroke, cardiovascular death, or hospitalization for heart failure(12 months)
- Change in cardiorespiratory fitnes(baseline and at 12 months)
- Interleukin-6(12 months)
- Changes in QoL questionnaires between baseline and 1 year(12 months)
- AF burden(baseline, than 6,9,12m and every 6 months)
- Fasting glucose(12 months)
研究者
Pavel Osmancik
head of the department of cardiac arrhythmias
Charles University, Czech Republic