Identification of a Risk Profile to Guide Atrial Fibrillation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Success of rhythm control
研究概览
简要总结
The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes in the atrial tissue and which can help predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, measurements obtained from echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to guide type of rhythm control therapy in individual patients with atrial fibrillation.
详细描述
Atrial fibrillation is responsible for substantial morbidity and mortality.Identification of patients with atrial fibrillation that is difficult to treat may improve the outcome of rhythm control therapy. Left atrial size could be a useful tool to select patients that will benefit from rhythm control therapy.Beside echocardiographic parameters,atrial fibrillation has been also associated with circulating biomarkers in blood like collagen metabolism, inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. Beside more accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive physical activity, esophageal problems and increased body mass index) may also predict the outcome of rhythm control.It likes also plausible that recurrent atrial fibrillation within one month after start of rhythm control are associated with a different risk profile than late atrial fibrillation recurrence.During this study we will try to identify patients with atrial fibrillation who are more or less likely to respond to rhythm control therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Short-lasting symptomatic paroxysmal or persistent AF;
- •Rhythm control strategy is preferred;
- •No contra-indication for oral anticoagulation;
- •Age > 18 years;
- •Written informed consent
排除标准
- •Total history of heart failure and/ or of severe valvular disease > 3 years;
- •Severe valvular disease;
- •Acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month;
- •Post-operative AF.
结局指标
主要结局
Success of rhythm control
时间窗: 12 month
(1) \< 1 second AF on end-of-study ECG; (2) \< 30 seconds AF on end-of-study 48-hour Holter recording; (3) no AF on end-of-study 2 weeks Vitaphone ECG-card recording.
次要结局
- Time to recurrence of (a)symptomatic AF(1+3+6+9+12 month)
- Cardiovascular morbidity and mortality(1month and 12month)
- Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF(1+3+6+9+12 month)
- Risk profiles associated with early versus late AF recurrence(1month and 12 month)
- Failure of rhythm control, i.e. permanent AF(1+3+6+9+12 month)
- Changes in atrial and ventricular echocardiographic parameters(1month and 12 month)
- Pulmonary vein ablation(1month, 3month, 6month, 9 month, 12month)
- Pathophysiological mechanisms associated with AF and success of rhythm control(baseline-12 months)
研究者
I.C. Van Gelder
MD. PhD
University Medical Center Groningen