Supervised Obesity Reduction Trial for AF Ablation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 7
- 主要终点
- The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation
研究概览
简要总结
Study hypothesis:
Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an obesity treatment after atrial fibrillation ablation.
Study design:
A prospective randomized, open-label clinical trial.
详细描述
Study protocol:
The purpose of this study is to proof a professional care of overweight patients with symptomatic atrial fibrillation, as well as the treatment of the risk factors for atrial fibrillation, especially obstructive sleep apnea and hypertension.
There is a 1:1 randomization. In the intervention group, patients are followed up in a 6-month intensive care after atrial fibrillation ablation. During the follow up time patients will visit the nutritional advice every two weeks for 6 months.
The Follow-up in the control group is standard of care. At baseline, a screening test for obstructive sleep apnea and arterial hypertension will be performed as standard care.
The documentation of atrial fibrillation after ablation is made possible by the implantation of an event recorder before atrial fibrillation ablation.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Overweight with a BMI ≥ 30
- •Obtained written informed consent
- •Symptomatic atrial fibrillation with indication for ablation
排除标准
- •Age <18 years
- •Permanent atrial fibrillation (failed Cardioversion or episode duration > 12 months)
- •Previous surgical or interventional therapy of atrial fibrillation
- •BMI > 40
- •Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
- •History of hemorrhagic diathesis or other coagulopathies
- •Contraindications for oral anticoagulation
- •Hyper- or hypothyroidism
- •Drug or chronic alcohol abuse
- •Has any condition that would make participation not be in the best interest of the subject
- •Incompliance
- •Unable to perform athletic exercise due to disease or disability
- •Resident outside Hamburg
结局指标
主要结局
The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation
时间窗: 12 months
AF burden is defined as overall percentage of AF during the observed period.
次要结局
- Body Mass Index (BMI) change from BL to 12 months(12 months)
- Exercise capacity change from BL to 12 months(12 months)
- AF burden between 0 and 12 months after first AF ablation(12 months)
- AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation(12 months)
- Freedom of AF (after 3 months blanking period)(12 months)
- Time to first recurrent AF (after 3 months blanking period)(12 months)
- Number of repeated AF ablation procedures(12 months)
- Mean blood pressure change from BL to 12 months(12 months)
- Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months(12 months)