Progression of Atrial Fibrillation in the Young
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Development of atrial fibrillation burden
研究概览
简要总结
The purpose of this study is to investigate the presence and magnitude of structural changes of the heart and their long-term development in young patients with atrial Fibrillation (AF), studied by echocardiographic measurements and plasma biomarkers and their association to AF burden, studied using long-term ECG
详细描述
100 patients with symptomatic Atrial Fibrillation diagnosis are included. Diagnosis is set either at the index visit or within 12 months before inclusion. . The follow up period is 5 years. Patients presenting with AF in connection with acute infection, acute cardiac ischemia, surgery or thyroid disease are excluded. Further, AF patients with cardiomyopathies, known genetic diseases and congenital cardiac abnormalities are also excluded.
At inclusion patients undergo an in-depth interview regarding comorbidities, medication, previous treatments related to the AF diagnosis. In addition, baseline data for weight and height are collected.
In connection to inclusion the patients are asked leave venous bloodwork (Na, K, Creatinine, plasma Glucose and NTproB-Type Natriuretic Peptide). An echocardiographic exam is performed according to a prespecified protocol with special emphasis on the left atrial function and anatomy. This is followed by a continuous ECG recording for 14 days using BioTel ePatch. The ECG patch is later returned to a core facility by mail.
The patients´ are followed for five years and are asked to leave bloodwork and perform a 14-day ECG recording yearly. After these exams, a follow up phone call is placed to the patient aimed at documenting clinical progress related to symptoms, treatment and interventions. After 5 years follow up patients undergo a follow up echocardiographic exam in addition to yearly bloodwork and ECG recording. The patients´ clinical symptoms are treated at the clinician´s discretion according to current guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial fibrillation
- •Diagnosis of atrial fibrillation within one year of inclusion
排除标准
- •Duration of atrial fibrillation over one year.
- •Acute stressor for atrial fibrillation such as: acute ischemic heart disease or infection
结局指标
主要结局
Development of atrial fibrillation burden
时间窗: change from baseline at 5 years
Change in burden of atrial fibrillation expressed as proportion of arrhythmia present on long-term ECG yearly
次要结局
- Development of atrial fibrillation incident(Change from baseline at 5 years)
- Development of echocardiographic status(Change from baseline at 5 years)
- Development of left atrial systolic function by echocardiography(Change from baseline at 5 years)
- Development of left ventricular systolic function by echocardiographic(Change from baseline at 5 years)
- Development of humoral measures of hemodynamic status(Change from baseline at 5 years)
- Development of atrial electrocardiographic status(Change from baseline at 5 years)
- Development of supraventricular ectopies(Change from baseline at 5 years)
- Development of left atrial volume by echocardiography(Change from baseline at 5 years)
研究者
Piotr Sobocinski Doliwa
Principal Investigator
Karolinska Institutet