Early Versus Late DC-cardioversion of Persistent Atrial Fibrillation. Effect on Atrial Remodeling,Inflammatory and Neurohumoral Markers and Recurrence of Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Difference in function and size of the left atrium, prior to and post cardioversion comparing early cardioversion to conventional treatment group. The data for comparison will be acquired echocardiographically
研究概览
简要总结
Atrial fibrillation (AF) is the most common arrhythmia present in 1% of population under 60 years of age and reaching up to 15% at 80 years. AF is associated with reduced quality of life, increased morbidity, mortality and health economic costs.
Presentation of AF differs substantially among patients ranging from self-limiting short episodes (paroxysmal AF), longstanding episodes (persistent AF) where direct current (DC) cardioversion is needed, to chronic atrial fibrillation. Treatment of AF is individually tailored in accordance to symptoms, type of AF and thromboembolic risk. The standard treatment of symptomatic persistent AF is DC-cardioversion preceded by anticoagulant treatment with Warfarin. According to guidelines DC-cardioversion can be performed when anticoagulation treatment has been in therapeutic range for at least 4 weeks. However introduction of Pradaxa (Dabigatran) has enabled an earlier DC cardioversion, reducing time to cardioversion to a 3 week period. During anticoagulation treatment persistence of AF contributes to left atrial remodeling and increases in inflammatory and neurohumoral biomarkers. The prolonged duration of AF and the remodeling of the left atrium increase the risk of AF recurrence after DC-cardioversion.
Early cardioversion of patients with persistent AF is possible if preceded by transesophageal echocardiography (TEE). The TEE guided DC- cardioversion, as demonstrated in the ACUTE study, is a safe and efficient alternative to conventional treatment. This treatment regime is not routinely used in clinical practice.
The aim of this study is to compare early DC-cardioversion (within 72 hours) to conventional treatment (Pradaxa prior to DC-cardioversion). 140 patients with persistent AF will be randomized to early cardioversion preceded by TEE in accordance with guidelines or conventional treatment with Pradaxa for 4 weeks prior to DC-cardioversion.
The investigators will determine the outcome in the two groups regarding:
- Left atrial function and size assessed by left atrial strain, left atrial ejection fraction and left atrial volume.
- Inflammatory and neurohumoral biomarkers including ANP, BNP,IL6 and CRP.
- Time to recurrence of AF (AF documented by ECG or Holter monitoring)
Comprehensive transthoracic echocardiography, 12 lead ECG, biomarkers and Holter monitoring will be performed at the time of randomization, 4 weeks, 3 month and 6 month post DC-cardioversion. Furthermore all patients will be followed for symptomatic AF recurrence for a period of one year. AF recurrence will be documented by 12 lead ECG.
详细描述
Background:
Atrial fibrillation (AF) is the most common arrhythmia, present in about 1 % of the population under 60 years of age and significantly higher among the older population, reaching up to 15 % in patients at 80 years. Worldwide, the proportion of people aged over 60 years is growing faster than any other age group. This will inevitably result in an increased prevalence of AF in the overall population. This is supported by the fact that the incidence of AF has increased over the past two decades. Furthermore a number of diseases which are associated with a higher prevalence of AF, such as ischemic heart disease (IHD), valvular heart disease, diabetes and hypertension are also expected to increase in prevalence due to the aging population. This again will contribute to an increased incidence of AF. Atrial fibrillation is associated with significant increase in mortality, morbidity and a reduction in quality of life.
The mechanisms behind AF including proliferation of fibroblasts, enhanced connective tissue deposition and fibrosis, all play an important part in structural remodeling of the left atrium. The structural remodeling leads to electrical deterioration which is fundamental for initiation of AF. The persistence of AF induces further electrophysiological remodeling, shortening of atrial refractoriness and in the end persistence of AF. The vicious cycle can, be reversed by restoration of sinus rhythm.
The treatments available today range from DC cardioversion, pharmacological rhythm and rate control, radiofrequency ablation to anticoagulation treatment.
If rhythm control is desired, cardioversion to sinus rhythm is achievable by DC-cardioversion. If AF is present less than 48 hours DC-cardioversion can be performed without further precautions. If AF is present more than 48 hours, DC cardioversion should be preceded by anticoagulation treatment with Warfarin for a minimum of 4 weeks or alternatively Pradaxa for 3 weeks prior to DC-cardioversion. Early cardioversion of patients with persistent AF > 48 hours is possible if preceded by transesophageal echocardiography (TEE) and exclusion of thrombus as demonstrated in the ACUTE trial.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to department of cardiology OUH Svendborg Hospital or referred to outpatient clinic with symptomatic persistent AF, duration more than 48 hours and indication for DC cardioversion. Atrial fibrillation must be verified by a 12 lead ECG. All patients must be over 18 years of age, and must provide written informed consent prior to inclusion.
排除标准
- •Reversible causes for AF (thyrotoxicosis, infection, pulmonary embolism), acute coronary syndrome and absolute contraindications of TEE (oesophageal spasm, stricture, perforation and diverticula). Patients with diminished mental capability will not be included.
研究组 & 干预措施
Conventional
Conventional treatment Pradaxa prior to DC cardioversion
干预措施: Pradaxa (Drug)
TEE
Transesophageal echo prior to DC cardioversion (early DC)
干预措施: TEE (Procedure)
Early versus Late DC cardioversion
Comparing early versus late DC cardioversion. Patients randomized to either early or late DC cardioversion, follow-up time after intervention 12 month.
干预措施: Compare TEE guided cardioversion to Dabigatran + DC cardioversion (Other)
结局指标
主要结局
Difference in function and size of the left atrium, prior to and post cardioversion comparing early cardioversion to conventional treatment group. The data for comparison will be acquired echocardiographically
时间窗: Baseline compared to 12 months post DC cardioversion
Difference in function and size of the left atrium, prior to and post cardioversion comparing early cardioversion to conventional treatment group. The data for comparison will be acquired echocardiographically
Difference in time to recurrence of, ECG or Holter verified AF, when comparing early cardioversion to conventional treatment.
时间窗: Baseline compared to 12 months post DC cardioversion
Difference in time to recurrence of, ECG or Holter verified AF, when comparing early cardioversion to conventional treatment.
Difference in levels of inflammatory (IL-6 & CRP) and neurohumoral markers (ANP & BNP) prior to and post cardioversion, when comparing early cardioversion to conventional treatment group.
时间窗: Baseline compared to 12 months post DC cardioversion
Difference in levels of inflammatory (IL-6 \& CRP) and neurohumoral markers (ANP \& BNP) prior to and post cardioversion, when comparing early cardioversion to conventional treatment group.
次要结局
- Difference in correlation between left atrial size and function and neurohumoral or inflammatory biomarker levels pre/post cardioversion, when comparing early cardioversion to conventional treatment group.(Baseline compared to 12 months post DC cardioversion)
研究者
Armin Osmanagic
Principal investigator
Odense University Hospital